Devices, methods, and systems to collect, store, and analyze chemical substances

ABSTRACT

Detection devices, systems, and methods include those for detecting analytes (e.g., volatile organic compounds (VOCs) and/or other chemical substances) from a target area of a subject&#39;s anatomy (e.g., a subject&#39;s skin, a wound on a subject, etc.). In some cases, a detector may have a detecting component that includes an analyte sensitive material applied to a substrate. The detector may be used with a pump. The detector may include a hydrophobic, gas permeable material configured to limit liquid reaching the analyte sensitive material, while allowing analytes in gaseous fluid to reach the analyte sensitive material.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Application No.PCT/US2021/058272, filed on Nov. 5, 2021, which claims priority to U.S.Provisional Application Ser. No. 63/111,077, filed Nov. 8, 2020, theentirety of which is incorporated herein by reference, U.S. ProvisionalApplication Ser. No. 63/114,734, filed Nov. 17, 2020, the entirety ofwhich is incorporated herein by reference, U.S. Provisional ApplicationSer. No. 63/128,048, filed Dec. 19, 2020, the entirety of which isincorporated herein by reference, U.S. Provisional Application Ser. No.63/128,050, filed Dec. 19, 2020, the entirety of which is incorporatedherein by reference, and PCT Patent Application No. PCT/US2021/053167,filed Oct. 1, 2021, the entirety of which is incorporated herein byreference, which claims priority to U.S. Provisional Application Ser.No. 63/087,128, filed Oct. 2, 2020, the entirety of which isincorporated herein by reference.

TECHNICAL FIELD

The present disclosure pertains to collection, storing, and analysistools, and the like. More particularly, the present disclosure pertainsto devices and systems for collecting, storing, and analyzing chemicalsubstances, and methods for manufacturing and using such devices.

BACKGROUND

A wide variety of medical devices have been developed in the medicalfield for collection, storing, and analysis of samples. These devicesare manufactured by any one of a variety of different manufacturingmethods and may be used according to any one of a variety of methods. Ofthe known medical devices and methods, each has certain advantages anddisadvantages.

BRIEF SUMMARY

This disclosure provides design, material, manufacturing method, and usealternatives for medical devices. Although it is noted that collection,storing and analysis approaches and systems are known, there exists aneed for improvement on those approaches and systems.

An example detector may include a detector array configured to detectone or more parameters of at least one analyte from a target location ofa subject's anatomy and a structure configured to orient the detectorarray adjacent the target location of the subject's anatomy and exposethe detector array to analyte from the target location.

Alternatively or additionally to any of the embodiments in this section,the structure is a substrate and the detector array may be located onthe structure.

Alternatively or additionally to any of the embodiments in this section,the structure may be a hydrophobic, gas permeable material.

Alternatively or additionally to any of the embodiments in this section,the structure may be configured to engage the subject's anatomy.

Alternatively or additionally to any of the embodiments in this section,the structure is flexible.

Alternatively or additionally to any of the embodiments in this section,the detector may include a cover extending over at least the detectorarray.

Alternatively or additionally to any of the embodiments in this section,the cover may be secured to the structure and the structure is a targetfacing component configured to engage the subject's anatomy.

Alternatively or additionally to any of the embodiments in this section,the cover may be transparent.

Alternatively or additionally to any of the embodiments in this section,the cover may be configured such that the detector array is analyzablethrough the cover.

Alternatively or additionally to any of the embodiments in this section,the detector array may be configured to be secured at a locationrelative to the target location of the subject's anatomy.

Alternatively or additionally to any of the embodiments in this section,the detector may include a band configured to be worn by the subjectagainst skin of the subject and wherein the detector array and thestructure are incorporated into the band such that the detector arraymay be exposed to the target location of the subject's anatomy throughthe structure when the band is worn by the subject.

Alternatively or additionally to any of the embodiments in this section,the band may form at least part of the structure.

Alternatively or additionally to any of the embodiments in this section,the detector may include a wound dressing configured to cover at least aportion of the detector array.

Alternatively or additionally to any of the embodiments in this section,the detector array may be a colorimetric sensor array (CSA).

Alternatively or additionally to any of the embodiments in this section,the detector array may have a control pattern having a firstconfiguration and an analyte sensitive pattern having a secondconfiguration that is at least substantially similar to the firstconfiguration, the control pattern may be configured to be non-reactiveto analytes from the subject, and the analyte sensitive pattern may beconfigured to react to analytes from the subject.

In a further example, a detector device may include a housing componentand a detecting component at least partially covered by the housingcomponent, and wherein the detecting component may be configured todetect one or more parameters of at least one analyte from a targetlocation on a subject's anatomy and the housing component is flexible.

Alternatively or additionally to any of the embodiments in this section,the housing component may be at least partially transparent.

Alternatively or additionally to any of the embodiments in this section,the housing component may include a target facing component and a covercomponent coupled to the target facing component.

Alternatively or additionally to any of the embodiments in this section,the cover component may be at least partially transparent.

Alternatively or additionally to any of the embodiments in this section,the target facing component may be a gas permeable membrane.

Alternatively or additionally to any of the embodiments in this section,the target facing component may be a gas impermeable membrane.

Alternatively or additionally to any of the embodiments in this section,the target facing component may be a hydrophobic membrane.

Alternatively or additionally to any of the embodiments in this section,the target facing component may be configured to direct a fluid flowincluding the at least one analyte from the target location of thesubject's anatomy to the detecting component.

Alternatively or additionally to any of the embodiments in this section,the detecting component may have an array of analyte sensitive materialconfigured to chemically react to the at least one analyte.

Alternatively or additionally to any of the embodiments in this section,the array of analyte sensitive material may be applied to a substrate.

Alternatively or additionally to any of the embodiments in this section,the substrate may be secured to the housing component.

Alternatively or additionally to any of the embodiments in this section,the housing component may comprise a cover.

Alternatively or additionally to any of the embodiments in this section,the detecting component may be configured to passively detect the one ormore parameters of at least one analyte from a target location on asubject's anatomy.

An example method of detecting analytes from a target location of asubject's anatomy may include preparing a surface of the target locationof the subject's anatomy for detection of analytes from the targetlocation, positioning a detector at a desired location and exposing adetecting component of the detector to analytes from the targetlocation, the detecting component including a substrate and analytesensitive material applied to a side of the substrate facing away fromthe target location, and analyzing the analyte sensitive material of thedetecting component after the detecting component is exposed to theanalytes from the target location.

Alternatively or additionally to any of the embodiments in this section,the detector may be configured to detect one or more parameters of ananalyte from skin of the subject and the target location is on a surfaceof the skin.

Alternatively or additionally to any of the embodiments in this section,the desired location may be a wound on the subject.

Alternatively or additionally to any of the embodiments in this section,positioning the detector at the desired location may include securingthe detector at the desired location.

Alternatively or additionally to any of the embodiments in this section,securing the detector at the desired location may include securing thedetector at the desired location with a band.

Alternatively or additionally to any of the embodiments in this section,securing the detector at the desired location may include securing thedetector at the desired location with an adhesive configured to adhereto skin of the subject.

Alternatively or additionally to any of the embodiments in this section,removing the detector from the desired location may include removing thedetector after a predetermined time at which the adhesive no longeradheres to the skin.

Alternatively or additionally to any of the embodiments in this section,the detector may be configured to be analyzed to identify analytesindicative of bacteria in a wound.

Alternatively or additionally to any of the embodiments in this section,the detector may be configured to be analyzed to identify analytesindicative of the subject's response to a therapy.

Alternatively or additionally to any of the embodiments in this section,the detector may be configured to be analyzed to identify analytesindicative of the subject's wellness.

Alternatively or additionally to any of the embodiments in this section,the detector may be configured to chemically react with the analytes andchange colors to identify one or more parameters of the analytes.

Alternatively or additionally to any of the embodiments in this section,exposing the detecting component to analyte from the target location mayinclude passively exposing the detecting component to analyte from thetarget location.

Alternatively or additionally to any of the embodiments in this section,exposing the detecting component to analyte from the target location mayinclude pumping fluid including the analyte across the detectingcomponent.

Alternatively or additionally to any of the embodiments in this section,the detector may include a hydrophobic, gas permeable componentpositioned between the desired location and the detecting component.

The above summary of some embodiments is not intended to describe eachdisclosed embodiment or every implementation of the present disclosure.The Figures, and Detailed Description, which follow, more particularlyexemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of thefollowing detailed description in connection with the accompanyingdrawings, in which:

FIG. 1 is a schematic perspective view of an illustrative detector on asubject's anatomy;

FIG. 2 is a schematic cross-sectional view of the illustrative detectorof FIG. 1 , taken along line 2-2;

FIG. 3 is a schematic top view of an illustrative detector;

FIG. 4 is a schematic bottom view of an illustrative detector;

FIG. 5 is a schematic top view of an illustrative detector;

FIG. 6 is a schematic end view of the illustrative detector depicted inFIG. 5 ;

FIG. 7 is a schematic top view of an illustrative detector;

FIG. 8 is a schematic cross-sectional view of the illustrative detectorof FIG. 7 , taken along line 8-8;

FIG. 9 is a schematic perspective view of an illustrative detectorincluding a band or strap on a subject's anatomy;

FIG. 10 is a schematic top view of an illustrative detector on asubject's anatomy;

FIG. 11 is a schematic cross-sectional view of the illustrative detectoron the subject's anatomy of FIG. 10 , taken along line 11-11;

FIG. 12 is a schematic bottom view of the illustrative detector depictedin FIG. 10 ;

FIG. 13A is a schematic top view of an illustrative detector prior toexposure to analyte;

FIG. 13B is a schematic top view of the illustrative detector of FIG.13A after exposure to analyte;

FIG. 14 is a schematic top view of an illustrative detecting component;

FIG. 15 is a schematic top view of an illustrative detecting component;

FIG. 16 is a schematic top view of an illustrative detecting component;

FIG. 17 is a schematic top view of an illustrative detecting component;

FIG. 18 is a schematic top view of an illustrative mask component foruse with the detecting component of FIG. 17 ;

FIG. 19 is a schematic side view of the illustrative mask componentdepicted in FIG. 18 ;

FIG. 20 is a schematic top view of an illustrative detector;

FIG. 21 is a schematic end view of the illustrative detector depicted inFIG. 20 ;

FIG. 22 is a schematic cross-sectional view of the illustrative detectorof FIG. 20 , taken along line 22-22;

FIG. 23 is a schematic cross-sectional view of an illustrative detector;

FIG. 24 is a schematic bottom view of the illustrative detector of FIG.23 ;

FIG. 25 is a schematic side view of the illustrative detector of FIG. 23in communication with a pump;

FIG. 26 is a schematic side view of an illustrative detector incommunication with a pump;

FIG. 27 is a schematic top perspective view of an illustrative detector;

FIG. 28 is a schematic cross-sectional view of the illustrative detectorof FIG. 27 , taken along line 28-28;

FIG. 29 is a schematic exploded view of the illustrative detector ofFIG. 27 ;

FIG. 30 is a schematic bottom perspective view of a base of theillustrative detector of FIG. 27 ;

FIG. 31 is a schematic bottom perspective view of a cover component ofthe illustrative detector of FIG. 27 ;

FIG. 32 is a schematic perspective of the illustrative detector of FIG.27 in communication with a pump;

FIG. 33 is a schematic perspective view of an illustrative detector;

FIG. 34 is a schematic exploded view of the illustrative detectordepicted in FIG. 33 ; and

FIG. 35 is a schematic flow diagram of an illustrative method ofdetecting analytes from a target area of a subject's anatomy.

While the disclosure is amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the invention tothe particular embodiments described. On the contrary, the intention isto cover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the disclosure.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about”, whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (e.g., having the same function orresult). In many instances, the terms “about” may include numbers thatare rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and5).

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

It is noted that references in the specification to “an embodiment”,“some embodiments”, “other embodiments”, etc., indicate that theembodiment described may include one or more particular features,structures, and/or characteristics. However, such recitations do notnecessarily mean that all embodiments include the particular features,structures, and/or characteristics. Additionally, when particularfeatures, structures, and/or characteristics are described in connectionwith one embodiment, it should be understood that such features,structures, and/or characteristics may also be used connection withother embodiments whether or not explicitly described unless clearlystated to the contrary.

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same or have similar tens and ones value, but a different hundredsvalue that is associated with a Figure number (e.g., a firstconfiguration depicted in FIG. 1 of a component may have a referencenumber of 1XX and a second configuration depicted in FIG. 6 of thecomponent may have a reference number of 6XX). The drawings, which arenot necessarily to scale, depict illustrative embodiments and are notintended to limit the scope of the invention.

Chemical substances (e.g., analytes) migrate from inside a subject'sbody to an exterior surface of the subject's anatomy (e.g., a skinsurface or other suitable surface) by diffusion across the epidermisfrom cutaneous capillaries, sweat glands (eccrine, and apocrine glands),and sebaceous glands. In addition, the epidermis of the skincontinuously sheds thousands of cells into the environment, which arereplaced by differentiating cells from the layer below. These dead cellstransport body secretions and importantly bacteria, which act on thedead cells and envelope them in a minute vapor cloud. Example substancesemitted, excreted, emanated, released, and/or secreted from, to, orthrough the exterior surface of a subject's anatomy include, but are notlimited to, sweat, water, minerals, natural compounds, xenobioticcompounds, sebum, protein degradation products, volatile organiccompounds (VOCs), and/or other suitable substances emitted from, to, orthrough the skin surface. Through changes in metabolic profiles ofchemical substances produced by the body, physiological and pathologicalinformation may be identified.

VOCs are chemical compounds containing carbon that have a high enoughvapor pressure under normal conditions to significantly vaporize andenter the atmosphere. VOCs and other chemical substances are producedfrom sweat and sebum as well as and in addition to their interactionswith resident skin or wound bacteria. VOCs are continuously beingproduced by a mammalian body's metabolism, including the metabolism ofthe human body, and released into the air predominantly via skin,breath, feces, and urine. Thus, VOCs can instantaneously reflect normalor abnormal physiological and pathological biochemical processesoccurring in the body at a time of measurement.

A complex profile of VOCs and/or other chemical substances emanates fromexterior surfaces of human anatomy (e.g., skin, wounds, etc.), which isaltered by changes in the body's metabolic or hormonal state, theexternal environment, and the bacterial species colonizing at theexterior surfaces. Based on this, bacterial biofilm formation in humanex vivo cutaneous wound models and their specific VOC profiles have beendeveloped. These models and profiles provide a vehicle for humanskin-relevant biofilm studies and VOC detection that has potentialclinical translatability in efficient non-invasive diagnosis of woundinfection, as discussed in Validation Of Biofilm Formation On Human SkinWound Models And Demonstration Of Clinically TranslatableBacteria-Specific Volatile Signatures, Ashrafi M, Novak Frazer L, BatesM, Baguneid M, Alonso-Rasgado T, Xia G, Rautemaa-Richardson R, Bayat A,Sci Rep. 2018 Jun. 21; 8(1):9431, doi: 10.1038/s41598-018-27504-z),which is hereby incorporated by reference in its entirety for any andall purposes.

Capture and identification of VOCs and other chemical substancesemanating from a target location of, on, or from a subject's anatomy(e.g., skin of a human body, wounds on the human body, feces or urinefrom the human body, exhalation from the human body, etc.) may beutilized for non-invasive, objective, and measurable monitoring and/oranalysis of metabolic pathways, and can also illustrate how thesepathways are altered and even respond to therapy in disease processes.For example, a change in a human body's metabolism equilibrium inresponse to a therapy can cause an alteration of VOCs and/or otherchemical substances produced from the human body that is measurable andis indicative of how the human body is responding to the therapy.

In addition, microorganisms release VOCs and/or other chemicalsubstances. The ability to identify these VOCs and/or other chemicalsubstances from microorganisms in infected cutaneous wounds of amammalian subject, such as a human being, results in efficientnon-invasive diagnoses.

Diagnostic procedures utilizing VOCs and/or other chemical substancesfrom a subject may be non-invasive and thus are an attractivealternative for patients compared to current invasive laboratory testsperformed in hospitals and/or other medical settings, which takesignificant time and cannot provide instant point of care testing. Inone example, use of VOCs to diagnose wound infections is discussed inVolatile Organic Compound Detection As A Potential Means Of DiagnosingCutaneous Wound Infections, Ashrafi M, Bates M, Baguneid M,Alonso-Rasgado T, Rautemaa-Richardson R, Bayat A, Wound Repair Regen,2017 August; 25(4):574-590. doi: 10.1111/wrr.12563, Epub 2017 Aug. 31,which is hereby incorporated by reference in its entirety for any andall purposes.

Various devices and system may be utilized to collect and/or analyzeVOCs and/or other chemical substances. Some devices used for collectionof VOCs and/or other chemical substances are configured to collect VOConto an adsorption pad. Example devices used for collection of VOCand/or other chemical substances are described in PCT Patent ApplicationNo. PCT/US21/53167, filed on Oct. 1, 2021, and titled DEVICES, METHODS,AND SYSTEMS TO COLLECT, STORE, AND ANALYZE CHEMICAL SUBSTANCES, which ishereby incorporated by reference in its entirety for any and allpurposes.

In order to analyze VOCs and/or other chemical substances collected onan adsorption pad, additional steps of transporting the VOCs and/orother chemical substances to an analysis system or location anddesorbing the collected VOCs and/or other chemical substances from theadsorption pad may be required, which take time and can add complexityto the collection and analysis of VOCs and/or other chemical substancesfrom a subject. Further, some devices or systems used for collection ofVOCs and/or other chemical substances are configured to gather VOCsand/or other chemical substances by inhalation of air or other gassesmixed with VOCs and/or other chemical substances. Use of such devices orsystems may result in obtaining a relative diluted mixture of gasses andVOC and/or other chemical substances, which may increase the difficultyof collecting and analyzing VOCs and/or other chemical substances thatmay be produced by a subject in relatively small volumes orconcentrations. In some cases, VOCs and/or other chemical substancesthat are collected at a subject may need to be transported or moved toremote analysis locations, which has the potential to dilute and/orcontaminate the collected VOCs and/or other chemical substances and addsto the complexity of the analysis and the length of time needed for theanalysis of the collected VOCs and/or other chemical substances.

The disclosed concepts provide devices, systems, and methods thatfacilitate collection and analysis of analytes (e.g., VOCs and/or otherchemical substances, etc.) from a target location on an exterior surfaceof a subject that may not require additional gasses or liquids tocollect the VOCs and/or other chemical substances and that mayfacilitate analysis of the VOCs and/or other chemical substances at acollection site. In one example, the devices, systems, and methods thatfacilitate collection and analysis of VOCs and/or other chemicalsubstances may include a device that incorporates a detector, where thedevice is configured to be located in proximity to an exterior surfaceof a subject's anatomy such that the detector may be exposed to VOCsand/or other chemical substances produced by the subject. In oneexample, the detector may be and/or may include a colorimetric sensorarray (CSA), but this is not required.

Additionally or alternatively to devices, systems, and methods thatfacilitate collection and analysis of analytes from a target location onan exterior surface of a subject, the devices, systems, and methodsdescribed herein may be utilized to detect and/or analyze analytes fromother suitable target locations of, on, or from the subject. Forexample, devices that facilitate analysis of and/or detection ofanalytes from a target location may be configured to detect analytesfrom exhalations (e.g., breath), urine, feces, throat cultures, woundcultures, and/or other suitable target locations of, on, and/or from thesubject. In some cases, the target locations and/or analytes from thetarget locations may be obtained or collected from the subject and thedevices, systems, and methods discussed herein may be utilized to detectand/or analyze such obtained or collected analytes or analytes from suchobtained or collected target locations at a location remote from thesubject or remote from the collection location.

Turning to the Figures, FIG. 1 depicts a schematic perspective view ofan illustrative detecting device or detector 100 positioned on a surface126 of a subject's skin 124 (e.g., a target location of the subject'sanatomy). In one example, the detector 100 may be configured to detectanalytes (e.g., VOCs and/or other chemical substances) from a mammalianbody, such as a human or other animal patient or subject. In some cases,the detected analytes may be of the types emitted, secreted, emanated,released, and/or excreted to, from, or through skin 124 and/or othersuitable anatomy of a subject.

The detector 100 may include one or more components. For example, thedetector 100 may include one or more of a target facing component 111, adetecting component 113, a cover component 115, and/or one or more othersuitable components as discussed herein or otherwise. Further, thefunctions and/or configurations of the target facing component 111, thedetecting component 113, the cover component 115, and/or other suitablecomponents of the detector 100 may be implemented in one or morephysical components formed from one or more materials, as desired. Inone example configuration of the detector 100, the detector 100 mayinclude at least the detecting component 113 configured to detectanalytes (e.g., VOCs and/or other chemical substances) emitted,secreted, emanated, released, and/or excreted to, from, or through theskin 124, wounds, and/or other suitable target locations of, on, or fromthe subject's anatomy, where the included detecting component 113 may ormay not take on certain functions or configurations, discussed herein,of the target facing component 111 and/or the cover component 115.

The detector 100 may be configured in layers and may include anysuitable number of layers, but this is not required, and other suitableconfigurations are contemplated. As depicted in FIG. 1 , the detector100 may include a first layer 112, a second layer 114, and a third layer116. In some cases, the first layer 112 may be configured as the targetfacing component 111, the second layer 114 may be configured as thedetecting component 113, and the third layer 116 may be configured asthe cover component 115, but this is not required, and the detector 100may have fewer than three layers, more than three layers, and/or layersformed from sub-layers.

The detector 100 may include a housing that is configured from one ormore materials of the one or more layers or components or configuredfrom one or more materials different than or separate from the one ormore materials of the one or more layers or components. In some cases,the target facing component 111 and the cover component 115 may form ahousing for the detecting component 113. Alternatively or additionally,a housing component may be configured to extend at least partiallyaround one or more of, including all of, the target facing component111, the detecting component 113, and the cover component 115 to housethe components of the detector 100.

As depicted in FIG. 1 , each of the target facing component 111, thedetecting component 113, and the cover component 115 have a same orsimilar diameter. Other configurations of the target facing component111, the detecting component 113, and the cover component 115 arecontemplated. In one example, the detecting component 113 may have adiameter or dimensions that is less than a diameter or dimensions of thetarget facing component 111 and/or the cover component 115, such thatthe target facing component 111 and/or the cover component 115 may forma housing around the detecting component 113. In another example, thetarget facing component 111 and the detecting component 113 may havediameters or dimensions that are less than a diameter or dimensions ofthe cover component 115, such that the cover component 115 may extendaround (e.g., cover) the target facing component 111 and the detectingcomponent 113 to form a housing that may contact a surface of the targetlocation and/or a surface adjacent the target location.

Further, the components of the detector 100 may be coupled together inany suitable manner. For example, the target facing component 111, thedetecting component 113, the cover component 115, and/or other suitablecomponents of the detector 100 may be attached or affixed to one anotherby use of adhesives, bonding techniques (e.g., ultrasonic welding, laserwelding, etc.), heat staking, clips, mechanical clips, over molding,printing the component on another component, friction fits, interlockingfeatures, one or more housings (e.g., as discussed above or otherwise),and/or other suitable coupling techniques.

The detector 100 may take on various suitable configurations. In oneillustrative configuration of the detector 100, the target facingcomponent 111 may be coupled to a first side of the cover component 115and the detecting component 113 may be coupled to the first side of thecover component 115 within an inner circumference of the couplingbetween the target facing component 111 and the cover component 115. Ina further illustrative configuration of the detector 100, the targetfacing component 111 may include a first side configured to face atarget location and a second side opposite of the first side, thedetecting component 113 may be coupled to the second side of the targetfacing component 111, and the cover component 115 may be coupled to thesecond side of the target facing component 111. In yet anotherillustrative configuration, the target facing component 111 may beomitted and the detecting component 113 may be coupled to a first sideof the cover component 115, such that the detecting component 113 may beexposed to analytes (e.g., VOCs and/or other chemical substances) fromthe target location. In yet a further illustrative configuration, thecover component 115 may be omitted and the detecting component 113 maybe coupled to the target facing component 111 at a side of the targetfacing component 111 opposite a side configured to face the targetlocation. Other suitable configurations are contemplated.

When the components and/or layers of the detector 100 are affixed orcoupled to one another, the components and/layers may be configured tobe separated from one another and/or permanently secured to one another.In one example configuration of the detector 100 including the targetfacing component 111, the detecting component 113, and the covercomponent 115, the detecting component 113 may be separated from thecover component 115 and the target facing component 111 such that thedetecting component 113 may be individually transported and/or analyzed.Such a configuration may allow for the re-use of all or some of thecomponents of the detector 100 and/or inserting a new detectingcomponent 113 into the detector 100. Additionally or alternatively, thedetecting component 113 may be analyzed at the detector 100.

The detector 100 may take on any suitable shape, profile, aspect ratio,and size to accommodate various usability, clinical, manufacturing,packaging, marketing, etc. factors. As depicted in FIG. 1 , the detector100 may take on a circular profile, although other suitable shapes(e.g., rectangular, square, hexagonal, ovoid, irregular, etc.) may beutilized.

Further, the detector 100, individual components thereof, and/orportions of components may be rigid, compliant, and/or flexible. Whenthe detector 100 is configured to contact the skin 124 of a subjectand/or an area at or around another target location, the rigidity,compliance, and/or flexibility of the components of the detector 100 maybe configured to create a desirable seal with the surface 126 of theskin 124 or area at or around another target location that facilitatesdetecting analytes from the exterior surface of the subject's anatomy(e.g., from a cutaneous surface or other suitable surface). In oneexample, the target facing component 111 may be a structure configuredto orient the detecting component 113 adjacent the target location ofthe subject's anatomy and expose the detecting component 113 to analytefrom the target location, and as such, may be configured to be compliantso as to conform to the surface 126 of the skin 124 or other anatomy ofthe subject. Further, a compliant and/or flexible detector 100 mayfacilitate manually creating gas turbulence within the detector 100 byapplying manual oscillating pressure to the cover component 115 to mixanalytes and promote circulation and efficient contact of analytes withthe detecting component 113.

The components 111, 113, 115 and/or layers 112, 114, 116 of the detector100 may be formed from any suitable materials or combinations ofmaterials. Example materials include, but are not limited to, wovenmaterial (e.g., a material formed from a matrix of threads and/or othersuitable woven material), porous materials, non-porous material, fabric,paper, filter material, plastic, rubber, glass, metal, aluminum,polymer, polyolefin, silicone, calcium sodium phosphosilicates (e.g.,bioglass), bioceramic, polycarbonate, polypropylene, polyethyleneterephthalate (PET), coatings, other suitable materials, and/orcomposites or combinations thereof. Further, the material of thecomponents of the detector 100 may be configured to form a rigiddetector 100, a flexible detector 100, a detector 100 having flexibleportions, a detector 100 having rigid portions, and/or a detector 100having one or more other suitably configured portions.

The components 111, 113, 115 of the detector 100 may each be formed fromone or more one or more materials and may be formed from one or moresub-components or layers. In one example, a component 111, 113, 115 ofthe detector 100 may be formed from two or more layers (e.g., where thelayers are entirely or at least partially overlapping) or adjacentsub-components (e.g., where the sub-components are entirely or at leastpartially non-overlapping) of a same material. In another example, acomponent 111, 113, 115 of the detector 100 may be formed from two ormore layers or sub-components, where at least one material is differentfrom another material of the layers or sub-components. In an example ofthe detecting component 113 including at least two or more layers orsub-components with at least one layer or sub-component formed from afirst material different from a second material of another layer orsub-component, the first material may be an analyte sensitive materialconfigured to detect a first type of analyte and the second material maybe an analyte sensitive material configured to detect a second type ofanalyte, but this is not required.

The target facing component 111 may be formed from any suitablematerial. Example materials used for forming the target facing component111 include, but are not limited to, plastic, rubber, glass, metal,aluminum polypropylene, polytetrafluorethylene, PET foam, polyurethanefoam, reticulated foam, adhesive foam, gas permeable materials, gasimpermeable materials, other suitable materials, and/or combinationsthereof. In one example, the target facing component 111 may be formedfrom polypropylene and may form a hydrophobic, gas permeable membranebetween the detecting component 113 and a target location, but this isnot required. Forming the target facing component 111 at least partiallyof a hydrophobic, gas permeable membrane may allow for gasses containinganalytes to reach the detecting component 113, while preventingcontamination of the detecting component 113 from liquids at or adjacentthe target location. Additionally or alternatively to forming the targetfacing component 111 from a hydrophobic, gas permeable membrane, thetarget facing component 111 may include vent holes define an openingbetween the target location and the detecting component 113, or includeother suitable openings, to facilitate gaseous analytes passing (e.g.,permeating) from the target location to the detecting component 113. Insome cases, the target facing component 111 may be formed from a gasand/or liquid impermeable material to facilitate creating a seal (e.g.,a hermetic seal or other suitable seal) with the cover component 115 atand/or around the target location to isolate the analytes emanating fromthe target location within the detector 100 for detecting by thedetecting component 113.

Further, the target facing component 111 may be entirely or at leastpartially flexible, pliable, and/or rigid. In one example, the targetfacing component 111 may be at least partially flexible, pliable, orcompliant so as to conform to a surface of a subject's anatomy (e.g.,conform to a surface of a subject's arm). In some cases, a flexible,pliable, or compliant target facing component 111 may facilitatecreating a seal with a subject's anatomy and isolating the analytesemanating from the target location within the detector 100.

The cover component 115 may be formed from any suitable material.Example materials used for forming the cover component 115 include, butare not limited to, plastic, rubber, glass, metal, aluminum, polymer,polyolefin, silicone, calcium sodium phosphosilicates (e.g., bioglass),bioceramic, polycarbonate, polypropylene, PET, polytetrafluorethylene,other suitable materials, and/or combinations thereof. In some cases,the cover component 115 may be porous, may be gas permeable, may havevent holes, may have a port, and/or otherwise be configured tofacilitate a flow of fluid containing analytes through the detector 100.Alternatively or additionally, the cover component 115 may be non-porousto facilitate maintaining analytes from a target location within thedetector 100 for detection.

In one example configuration, the cover component 115 may be atransparent (e.g., clear or otherwise transparent to human eyes and/orviewing technologies) material (e.g., a transparent polymer materialand/or other suitable material) that may allow for viewing and/oranalyzing the detecting component 113 through the cover component 115. Atransparent or clear cover component 115 may facilitate heating thesubject's anatomy through the cover component 115 using infrared lightand/or other heating sources to increase analyte production from thesubject's anatomy. Further, a material of a transparent or clear covercomponent 115 may be configured to provide optical magnification that isconfigured to magnify a view of analyte sensitive material of thedetecting component 113 to help facilitate the analysis process throughthe cover component 115. Additionally or alternative, a transparent orclear cover component 115 may be configured as a filter so as to filtercertain wavelengths of light and cause changes in analyte sensitivematerial of the detecting component 113 to be more readily viewableand/or understandable relative to not using a filter.

Further, the cover component 115 may be entirely or at least partiallyflexible, pliable, and/or rigid. In one example, the cover component 115may be at least partially flexible, pliable, or compliant so as tofacilitate the detector 100 conforming to a surface of a subject'sanatomy (e.g., conform to a surface of a subject's arm). In some cases,a flexible, pliable, or compliant cover component 115 may facilitateisolating and/or producing the analytes emanating from the targetlocation within the detector 100.

Although not depicted in FIG. 1 , the target facing component 111, thecover component 115, and/or other suitable components of the detector100 may include one or more openings. In some cases, the opening(s) mayfacilitate a fluid flow (e.g., air flow) through or across the detector100, facilitate creating turbulence within the detector 100, etc., butthis is not required. In one example, the cover component 115 mayinclude a single opening extending through a top of the cover component115, but configurations with additional or alternative openingconfigurations are contemplated.

Although not required, the opening of the cover component, whenincluded, may be a vacuum port configured to engage a vacuum producingdevice via any suitable air-tight connection. In one example, theopening may be fitted or integrated with a nipple, protrusion, and/orother suitable component or configuration to facilitate connecting avacuum tube or similar receptacle to the detector 100. The nipple,protrusion, and/or other suitable component or configuration may be madefrom any suitable materials including, but not limited to, polylacticacid and/or other suitable material to facilitate creating a pressuregradient that enhances a flow of analytes from a target location of oron the subject's anatomy to the detecting component 113.

The detecting component 113 may be configured from one or more materialsthat are selected for one or more purposes including to, but not limitedto, detect or react in response to contact with one or more types ofanalytes (e.g., VOCs and/or other suitable chemical compounds from atarget location). In one illustrative configuration, the detectingcomponent 113 may include one or more analyte sensitive materials (e.g.,a detector array) applied to one or more sides of a substrate. In oneexample, the detecting component 113 may be a colorimetric sensor array(CSA) or fluorometric sensor array (FSA), but this is not required, andother suitable arrays or configurations of analyte sensitive materialare contemplated. Further, the materials of the detecting component 113may be selected to form a detection component 113 that is entirely or atleast partially rigid, pliable, and/or flexible. Alternatively oradditionally, the detecting component 113 may be entirely or at leastprimarily configured from analyte sensitive material.

The substrate of the detecting component 113, when included, may be astructure configured to orient the analyte sensitive materials adjacentthe target location of the subject's anatomy and expose the analytesensitive materials to analyte from the target location, and may beformed from any suitable material. Example materials utilized for thesubstrate of the detecting component 113 include, but are not limitedto, plastic, rubber, glass, paper, filter material, fabric, wovenmaterial, metal, aluminum, polypropylene, polytetrafluorethylene, othersuitable materials, and/or combinations thereof. Further, the materialutilized for the substrate of the detecting component 113 may be a solidmaterial, a woven material, a hydrophobic material, a gas permeablematerial, a gas impermeable material, other suitable materials, and/orcombinations thereof. In some cases, the substrate may have any suitabledimensional properties (e.g., pore size, diameter, area, volume, etc.)

In one example configuration of the substrate for the detectingcomponent 113, the substrate of the detecting component 113 may beformed from a woven polypropylene material, which may result in a gaspermeable, hydrophobic substrate. Although other pore sizes arecontemplated, in the example configuration, the woven substrate may havean average pore size of or about 0.2 microns and a diameter of about 25millimeters (mm). Such a configured substrate may facilitate applyingthe analyte sensitive material of the detecting component on a side ofthe substrate opposite a side facing a target location so that thehydrophobic material of the substrate mitigates the chances of and/orprevents liquid fluid from the target location contaminating the analytesensitive material of the detecting component 113, while allowinganalyte to reach the analyte sensitive material.

Additionally or alternatively, an example configuration of the substratefor the detecting component 113 may be fabricated from a hydrophobic,gas permeable material that has sufficient structural integrity to formthe entire detector 100, along with the analyte sensitive material,(e.g., omit the target facing component 111 and the cover component 115,and/or other housing components). Such a configured substrate may becomprised of one or more gas permeable materials that provide a desiredset of structural properties and gas permeability. In another exampleconfiguration of the substrate, the substrate may be formed entirely orat least in part by the cover component 115 and the analyte sensitivematerial may be applied to the cover component 115. In a further exampleconfiguration of the substrate, the substrate may be formed entirely orat least in part by the target facing component 111 and the analytesensitive material may be applied to the target facing component 111.

The analyte sensitive material of the detecting component 113 may beformed from any suitable material. In some cases, the analyte sensitivematerial may be an optically responsive chemical material that changescolor in response to detecting one or more analytes. Example analytesensitive materials include dyes from, but not limited to, the followingclasses: Lewis acid/base dyes (e.g., metal on containing dyes), Brenstedacidic or basic dyes (e.g., pH indicators), dyes with large permanentdipoles (e.g., solvatochromic dyes), redox responsive dyes (e.g., metalnanoparticle precursors), and/or other suitable classes of dyes. Oneexample analyte sensitive material may be a silver nanoparticlematerial. Other suitable analyte sensitive materials are contemplated,including analyte sensitive material that is not a printed dye.

One or more analyte sensitive material(s) (e.g., dyes or other suitablematerials) may be selected for the detecting component 113 based on atype of analyte (e.g., a VOC indicative of a bacteria or othercondition) the detector 100 is configured to detect. For example, theanalyte sensitive material(s) for the detecting component 113 may beselected so as to facilitate detecting analytes indicative of one ormore types of bacteria or conditions including, but not limited to,pathogens, a subject's health, cancer, odor causing bacteria, microbiotaconditions, pheromones, urinary tract infections, Streptococcus Pyogenes(SP), Methicillin Sensitive Staphylococcus Aureus (MSSA), PseudomonasAeruginosa (PA), and/or other suitable types of bacteria and/orconditions. In one example of analyte sensitive material of thedetecting component 113, the analyte sensitive material may be anacid/base combination of dyes that is configured to detect analytes(e.g., propanol, butanol, undecane, ethanol, etc.) that may be givenoff, released, or otherwise produced in a response to a presence ofStreptococcus Pyogenes.

Some detecting components 113 may be configured to include an analytesensitive material that is reversible or semi-reversible. Reversible orsemi-reversible analyte sensitive material may be utilized in detectingcomponents 113 that may be configured for repeat monitoring, such as forcontinuous or periodic sensing of target locations to detect analytesfrom the target locations. Although other detecting components 113 arecontemplated, example detecting components 113 including analytesensitive material that is reversible or semi-reversible are discussedin U.S. Pat. No. 6,368,558 filed on Mar. 21, 2000, and titledCOLORIMETRIC ARTIFICIAL NOSE HAVING AN ARRAY OF DYES AND METHOD FORARTIFICIAL OLFACTION; U.S. Pat. No. 6,495,102 filed on Nov. 11, 2000,and titled COLORIMETRIC ARTIFICIAL NOSE HAVING AN ARRAY OF DYES ANDMETHOD FOR ARTIFICIAL OLFACTION; U.S. Pat. No. 7,261,857 filed on Oct.24, 2002, and titled COLORIMETRIC ARTIFICIAL NOSE HAVING AN ARRAY OFDYES AND METHOD FOR ARTIFICIAL OLFACTION; U.S. Pat. No. 8,852,504 filedon Oct. 11, 2007, and titled APPARATUS AND METHOD FOR DETECTING ANDIDENTIFYING MICROORGANISMS, all of which are hereby incorporated byreference in their entirety and for all purposes.

Some detecting components 113 may be configured to include an analytesensitive material that is irreversible. Irreversible analyte sensitivematerial may be utilized in detecting components 113 that are configuredfor single use monitoring or single use monitoring per analyte materialwhen the detecting component 113 is configured to monitor for aplurality of different analytes, but this is not required. Althoughother detecting components 113 are contemplated, example detectingcomponents 113 including analyte sensing material that is irreversibleare discussed in U.S. Pat. No. 9,880,137 filed on Sep. 2, 2009, andtitled COLORIMETRIC SENSOR ARRAYS BASED ON NANOPOROUS PIGMENTS; U.S.Pat. No. 10,539,508 filed on Jun. 9, 2015, and titled PORTABLE DEVICEFOR COLORIMETRIC OR FLUOROMETRIC ANALYSIS AND METHOD OF CONDUCTINGCOLORIMETRIC OR FLUOROMETRIC ANALYSIS; Li, Zheng, et al.,“Ultrasensitive Monitoring of Museum Airborne Pollutants Using a SilverNanoparticle Sensor Array”, ACS sensors 5.9 (2020): 2783-2791; Li,Zheng, and Kenneth S. Suslick, “Chemically Induced Sintering ofNanoparticles”, Angewandte Chemie 131.40 (2019): 14331-14334; LaGasse,Maria K., et al., “Colorimetric sensor arrays: Development andapplication to art conservation”, Journal of the American Institute forConservation 57.3 (2018): 127-140, all of which are hereby incorporatedby reference in their entirety and for all purposes.

The analyte sensitive material may be applied to the substrate of thedetecting component 113 in any suitable manner. In one example, theanalyte sensitive material may be applied to the substrate by printingthe analyte sensitive material on the substrate. When printed, anysuitable printing techniques may be utilized including, but not limitedto, pin transfer, inkjet, silkscreen, and/or other suitable applicationtechniques.

The analyte sensitive material may be applied to the substrate of thedetecting component 113 randomly and/or to form one or more patterns.Example configurations of the analyte sensitive material applied to thesubstrate include, but are not limited to, grid patterns of rows andcolumns, concentric rings, color matching of a color of printed dyematerial with a color of a substrate material prior to interactions withanalyte, patterns that result in identifiable shapes when the analytesensitive material reacts to a particular analyte, other suitableconfigurations, and/or combinations thereof.

To increase analyte detection rates, the substrate on which the analytesensitive material is applied and/or the analyte sensitive materials maybe textured (e.g., with grooves or surface topographical undulations,woven patterns, etc.) so as to increase an effective surface area of theanalyte sensitive material for detecting analytes. Such texturing may beapplied to the target-contacting or facing surface (e.g., a bottomsurface 120) of the detector 100 in any suitable technique including,but not limited to, via etching, thermoforming, pressure forming,molding, machining, weaving, three-dimensional printing, and/or othersuitable techniques.

Further, the detector 100 may be used and/or configured to stimulateanalyte production from a subject's anatomy. Any suitable technique maybe utilized for inducing analyte production including, but not limitedto, the techniques discussed herein.

The detector 100 may include and/or be used with skin penetratingagents, such as Transcutol®, polyethylene glycol 400 (PEG 400),polyethylene glycol 200 (PEG 200), menthol and salicylic acid, which,for example, may be utilized to enhance delivery of sweat stimulatingchemical agents to the skin 124 of the subject. Alternatively oradditionally, iontophoresis techniques can be employed to drive sweatinducing agents into the skin of a subject to increase sweat production.In some cases, gasses or other fluids may be pumped to the skin of thesubject or other target location to induce a flow of analytes (e.g.,VOCs and/or other chemical substances) from the subject.

In some cases, the detector 100 may include one or more heat producingcomponents that may heat the surface 126 of the subject's skin 124 orheat a portion of the detector 100 (e.g., the bottom surface 120 and/orother suitable portion of the detector 100). When the heat producingcomponent is included in the detector 100, the heating of the detector100 may be controlled by a control of or separate from the detector 100.Examples of heat producing components include, but are not limited to,heating coils, resistive wires, surface mount (SM) resistors, Peltiertemperature control components (e.g., which may be used to heat and/orcool)) and/or other suitable components. In one example incorporation ofa heat producing component, the detector 100 may utilize one or moreheating coils configured to heat the bottom surface 120 of the detector100 and induce the subject to sweat at and/or proximate to the detector100.

Further, the detector 100 may include one or more sensors, which mayinclude or be in communication with a controller. For example, thedetector 100 may include a temperature sensor, a humidity sensor, apressure sensor, and/or one or more other suitable sensors. In oneexample, when the detector 100 includes a heat producing component, thedetector 100 may include a temperature sensor and a pressure sensor,where the heat producing component may be configured to cease heating inresponse to a sensed temperature crossing a threshold, a sensed pressurecrossing a threshold, and/or a sensed temperature crossing a temperaturethreshold and a sensed pressure crossing a pressure threshold.

FIG. 2 depicts a schematic cross-sectional view of the detector 100,taken along line 2-2 in FIG. 1 . Arrow F depicts a flow of analyte fromthe subject's skin 124 to the detecting component 113.

In some cases, the bottom surface 120 of the detector 100 may beconfigured to contact and/or engage a surface at or adjacent to a targetlocation, such as a subject's skin or wound or other suitable targetlocation. In some cases, the bottom surface 120 and/or the target facingcomponent 111 may be flexible or pliable to facilitate conforming to ashape of a surface of a subject's anatomy, but other configurations arecontemplated including, but not limited to, target facing components 111that are rigid and/or detectors 100 having an additional targetcontacting surface for conforming to a shape of the surface of thesubject's anatomy.

Although not required, the bottom surface 120 may be configured toadhere to the subject's skin 124 or other surface at or adjacent to atarget location such that the detector 100 may remain at a desiredlocation after being initially placed. The bottom surface 120 may haveany suitable configuration for adhering to a surface at or adjacent atarget location (e.g., the surface 126 of the skin 124, the surface ofor adjacent to a wound, etc.) including, but not limited to, aconfiguration that facilitates a suction connection, an adhesive (e.g.,a biocompatible adhesive attached to, impregnated in, or deposited onthe bottom surface 120 and/or other suitable adhesive applied in one ormore additional or alternative manners)), and/or other suitableconfiguration. In one example, the target facing component 111 may be ormay include an adhesive layer (e.g., an adhesive-backed ring and/orother suitable adhesive layer) to adhere to the surface 126 of thesubject's skin 124 in order to create a seal and to hold the detector100 in place during collection of VOCs and/or other chemical substances.When creating the seal, the adhesive layer may be configured to createan airtight seal (e.g., a hermetic seal) or approximately airtight sealthat prevents ambient air from leaking past the seal into the detector100 once a vacuum (e.g., negative pressure) is applied thereto orotherwise. In other configurations, non-hermetic seals and/or couplingsmay be utilized.

The detector 100 may be configured to adhere to a surface at or adjacentthe target location (e.g., skin 124 of the subject or other surface) forany suitable length of time. In one example, the bottom surface 120and/or other portions of the detector 100 may be configured to adhere toa subject's skin 124 or other suitable surface for at least a durationsufficient to allow analyte sensitive material to react to otherwisedetect analytes from the subject. In some cases, a material adhering thedetector 100 to the subject's skin 124 or other suitable surface may beconfigured to release or separate from the subject's skin 124 or othersuitable surface after a predetermined time, but this is not required.

As depicted in FIG. 2 , the bottom surface 120 may define a space or anopening 122 through a thickness of the target facing component 111(e.g., first layer 112) to the detecting component 113 (e.g., the secondlayer 114) and/or the cover component 115. In some cases, the detectingcomponent 113 may be gas permeable or otherwise include one or moreopenings such that a flow of analyte through the opening 122 in thetarget facing component 111 may reach analyte sensitive material of thedetecting component 113, but this is not required.

In some cases, the opening 122 may define a sample area. When thedetector 100 is applied to a subject's anatomy, the opening 122 and thesample area may be positioned around a target location of a subject'sanatomy from which analytes are to be detected.

The opening 122 may be configured such that an inner profile orcircumference of the target facing component 111 may take on a shapethat complements (e.g., in the depicted example is concentric to) ashape of the outer profile or circumference of the target facingcomponent 111 and/or the detector 100. Although FIGS. 3 and 4 (discussedbelow) depict the opening 122 as having a circular profile, otherprofiles or shapes for the opening 122 may be used and such profiles orshapes may or may not render or complement a similar outer profile ofone or more of the target facing component 111, the detecting component113, the cover component 115, and/or the detector 100.

Further, the bottom surface 120 of the detector 100 may include one ormore portions that comprise one or more holes, channels, and/or othersuitable voids configured to create a capillary action during use of thedetector 100 to assist in drawing analytes and/or secretions from thetarget location of or on the subject toward the detecting component 113.When the target facing component 111 is so configured, negative and/orpositive pressure (e.g., as discussed further, below) may or may not beutilized to draw fluid from the target location toward the detectingcomponent 113.

In the configuration depicted in FIG. 2 , the detecting component 113may be sized to extend across an opening 122 at least partially definedby a bottom surface 120 of the target facing component 111 to facilitatedetecting analytes emitted, excreted, secreted, emanated, or releasedfrom a target location of or on the subject's anatomy (e.g., the surface126 of the subject's skin 124, a wound on the subject, etc.). In oneexample, the detecting component 113 may have a circular disc shape, butthis is not required and other shapes are contemplated.

FIG. 3 depicts a schematic top view of an illustrative detector 100having a circular configuration, but this is not required and othersuitable shapes and/or configurations are contemplated. The detector 100may include the cover component 115 (e.g., a transparent cover component115, as depicted, or other suitable cover component 115), the detectingcomponent 113, and the target facing component 111, where the covercomponent 115 is transparent and the detecting component 113 and thetarget facing component 111 may be viewed through the cover component115 in a top view.

As depicted in FIG. 3 , the target facing component 111 may be formed asa ring that has an outer circumference aligned with an outercircumference of the cover component 115. Further, the ring shape of thetarget facing component 111 may include an inner circumference having adiameter configured to facilitate analytes from the subject's anatomyreaching the detecting component 113. Although not required, when thetarget facing component 111 is applied to the subject anatomy, the innercircumference of the target facing component 111 may define the desiredlocation (e.g., the sample area) at the target location on the subject'sanatomy from which the analytes are to be detected.

The detecting component 113 depicted in FIG. 3 includes a plurality ofdots formed from analyte sensitive material 128 on a substrate 130. Asdepicted, the dots are configured in rows and columns on the substrate130 having a square configuration, but this is not required.

As discussed in greater detail below with various exampleconfigurations, the analyte sensitive material 128 may be applied to thesubstrate 130 so as to have any suitable configuration that can bevisually understood and/or analyzed by human vision and/or computervision techniques. Further, the analyte sensitive material 128 may beconsidered as a detector array, on its own, that is applied to thesubstrate 130 and/or the analyte sensitive material 128 applied to thesubstrate 130 and/or other suitable materials may be considered adetector array.

The substrate 130 may have any suitable shape as discussed or depictedherein and/or otherwise. In some cases, the substrate 130 may be astructure configured to orient the analyte sensitive material 128adjacent the target location of the subject's anatomy and expose theanalyte sensitive material 128 to analyte from the target location. Forexample, the substrate 130 may be applied to an area of or adjacent tothe target location, the substrate 130 may be secured to or relative tothe cover component 115 and/or the target facing component 111, etc. insuch a manner that the analyte sensitive material 128 may be exposed toanalyte from the target location.

The detecting component 113, as depicted in FIG. 3 , may be coupled tothe cover component 115. In some cases, the substrate 130 of thedetecting component 113 may be coupled to the cover component 115 withany suitable coupling technique discussed herein or otherwise, whileallowing for analysis of the detecting component 113 through the covercomponent 115, but this is not required.

FIG. 4 depicts a schematic bottom view of the illustrative detector 100shown in FIG. 3 , where the target facing component 111 at leastpartially defines the opening 122 through and in which analytes from thesubject's anatomy are configured to travel to the detecting component113. As depicted, a back surface of the substrate 130 may be viewedthrough the opening 122 defined by the target facing component 111. Asthe dots of the analyte sensitive material 128 are applied to the frontsurface of the substrate 130 in this configuration, the analytesensitive material 128 is depicted in broken lines to indicate theanalyte sensitive material 128 is applied to the front surface of thesubstrate 130 (or an opposite than is depicted in FIG. 4 ) and theanalyte sensitive material 128 may or may not be viewed from the side orview depicted in FIG. 4 . In some cases, however, the analyte sensitivematerial 128 may be applied to the back side of the substrate 130 inaddition to or as an alternative to the front side. Alternatively oradditionally, the analyte sensitive material 128 may be applied to oneof the front side and the back side of the substrate 130 and due to aconfiguration of the substrate 130 (e.g., a woven material of thesubstrate 130 or other suitable configuration), the analyte sensitivematerial 128 may be absorbed into or through, may leak through, orotherwise move to the other of the back or front side and/ortherebetween once it is applied to a side of the substrate 130 so as toincrease a surface area of detection for the analyte sensitive material.

FIG. 5 depicts a schematic top view of an illustrative detector 100having a rectangular shape and configured in a manner similar to thedetector depicted in FIGS. 3 and 4 . The detector 100 depicted in FIG. 5may include a clear or transparent top layer 115 and a target facingcomponent 111 having an outer circumference that aligns with an outercircumference of the cover component 115. Further, an innercircumference of the target facing component may define the opening 122through which analyte may flow or travel to the detecting component 113.

Similar to as discussed with respect to FIGS. 3 and 4 , the detectingcomponent may include dots of analyte sensitive material 128 applied tothe substrate 130. Although other configurations are contemplated, theanalyte sensitive material 128 may be applied to the rectangularsubstrate 130 in rows and columns or in other suitable patterns.Further, the detecting component 113 may be affixed to the covercomponent 115 through any suitable coupling technique discussed hereinor otherwise, such that the detecting component 113 response to analyteexposure may be analyzed through a transparent or clear cover component115, as depicted in FIG. 5 .

FIG. 6 depicts an end view of the detector 100 depicted in FIG. 5 . Asdepicted in FIG. 6 , the target facing component 111 extending betweenthe bottom surface 120 and the cover component 115 and may have a heightthat is greater than a height of the cover component 115 and a height ofthe detecting component 113, but this is not required. In some cases,the height of the target facing component 111 may facilitate conformingthe detector 100 to a subject's anatomy. Further, as depicted, thedetecting component 113 may be affixed to the cover component 115 viaany suitable coupling technique that facilitates or at least does notfrustrate analysis of the detecting component 113 through the covercomponent 115.

FIG. 7 depicts a detector 100 that is configured in a manner that issimilar to the detector 100 depicted in FIG. 5 , however, the detector100 in FIG. 7 includes supports 132 extending to or toward a plane ofthe bottom surface 120. In some cases, the supports 132 may extendthrough the opening 122 defined by the cover component 115 and thetarget facing component 111 to a surface on which the detector 100 isapplied and facilitate maintaining a space or plenum between thedetecting component 113 and the subject's anatomy or other surface towhich the detector 100 may be applied. As depicted in FIG. 7 , thedetecting component 113 is positioned within the opening 122 and coupledto a transparent or clear cover component 115, such that the analytesensing material 128 and the substrate 130 are viewable through thecover component 115.

FIG. 8 depicts a cross-sectional view of the detector 100 taken alongline 8-8 in FIG. 7 and facing away from the detecting component 113depicted in FIG. 7 . As depicted, the detector 100 may include supports132 formed by the cover component 115 that extend through the opening122, which may be configured to contact a surface on which the detector100 is applied and space the detecting component 113 from the surfacewhen the detector 100 is applied thereto. Although the supports 132 aredepicted as being formed by the cover component 115, it is contemplatedthat the supports 132 be formed from and/or be a component separate fromthe cover component 115.

In some cases, the detectors 100 depicted in FIGS. 1-8 and/or otherdetectors discussed herein may include a seal or release liner extendingalong the bottom surface 120 and over the opening 122 to keep thedetecting component 113 sealed for protecting, not exposed to ambientconditions, sterile, and/or to otherwise maintain a virgin state andprotect against contamination. The seal or release liner may be formedfrom any suitable material including, but not limited to, high-densitypolyethylene materials. Further, to protect the detecting component fromcontamination and/or for other suitable purposes, an inert gas (e.g.,nitrogen, etc.) may be applied to the opening 122 and sealed therein bythe seal or release liner, but this is not required.

When the detector 100 is to be applied to the subject's anatomy or othersuitable surface and includes a seal or release liner, the seal orrelease liner may be removed from the bottom surface 120 and the bottomsurface 120 may be applied to subject's anatomy such that analyte maytravel from the surface through the opening 122 to the detectingcomponent 113. In some cases, when the target facing component 111forming the bottom surface 120 may be or may include adhesive material,the seal or release liner may be removed from the bottom surface 120 andthe bottom surface 120 may be adhered to the subject's anatomy.

The detector 100 may be provided in a sterilized packaging (e.g., asterilized double packaging, such as a pressure molded plastic tray witha cover made of TYVEK, which is a trademark for certain syntheticbarriers that is owned by E. I. du Pont de Nemours and Company, and/orother suitable sterilized packaging). The detector 100 and/or thepackaging may be sterilized using any suitable sterilization techniqueincluding, but not limited to, heat techniques, electron-beamtechniques, gamma radiation techniques, ethylene oxide techniques,and/or other suitable sterilization techniques that may be suitable foruse with detecting components 113.

Additionally or alternatively to the configurations of the detector 100depicted in FIGS. 1-8 , the detector 100 including at least thedetecting component 113 may be formed as or may be incorporated in aband, strap, or other wearable component that is configured to be wornby a subject in contact with the subject's skin 124 or otherwise suchthat the detector 100 receives analytes from a target location of or onthe subject's anatomy (e.g., the skin 124, a wound of the subject,etc.). Example bands, straps, and/or wearables include, but are notlimited to, wristbands, waistbands, ankle bands, arm bands, leg bands,headbands, equipment strap, watchbands, headphones, hats, eyeglasses,helmets, a wound dressing, a bandage (e.g., for adherence directly overa wound and/or around a wound dressing), etc.

The detector 100 incorporated into or taking the form of a band, strap,and/or other wearable may facilitate applying the detector 100 to or atthe target location, facilitate comfortably wearing the detector 100 forlong periods of time to detect and/or interact with a desired volume ofanalytes to detect a presence of an analyte type, condition, bacteria,and/or pathogen, and/or may have one or more other suitable benefits.Further, once the detector 100 formed as a band, strap, and/or otherwearable has detected and/or interacted with a desired amount ofanalytes from the subject wearing the detector 100, the subject or thirdparty (e.g., family member, health care provider, technician, friend,etc.) may remove the detector 100 from the subject and analyze thedetecting component 113 to determine which, if any, analytes weredetected and/or place the detector 100 or a portion of the detector 100(e.g., the detecting component 113) in contact with analytes from thesubject into an appropriate container for transport and furtheranalysis.

When the detector 100 is configured as or in a band, strap, or otherwearable, the detector 100 or at least the detecting component 113 maybe permanently integrated with the band, strap, or other wearable suchthat the detector 100 or at least the detecting component 113 cannot beremoved from the wearable without destroying the wearable. When thedetecting component 113 is permanently integrated with the band, strap,or other wearable, the analyte sensitive material of the detectingcomponent 113 may be analyzed while the detecting component 113 is partof the band, strap, or other wearable. Alternatively or additionally,the detector 100 or at least the detecting component 113 may beseparable from or releasably engaged with the band, strap, or wearableportion such that at least the detecting component 113 may be removedfrom the wearable portion to facilitate analyzing the analyte sensitivematerial of the detecting component 113.

The band, strap, or other wearable may be comprised of various layers orcomponents in combination as described herein. In some cases, a layer ofthe detector 100 formed as a band, strap, or other wearable thatincludes the detecting component 113 may be formed with and/or utilizecapillary pores or channels to draw sweat or sebum or other chemicalsubstances from the target area of the subject wearing the band, strap,or other wearable and direct the analytes from the subject onto and/orinto the detecting component 113.

The band, strap, or other wearable may include and/or may be formed ofone or more suitable materials. For example, the band, strap, or otherwearable may be formed from, among other suitable materials, anadsorbent material, a non-adsorbent material, an analyte sensitivematerial, hydrophobic material, gas permeable material, a wovenmaterial, gauze, polymers, metals, fabrics, paper, coatings, etc. In oneexample configuration of a detector 100 formed as or in the band, strap,or other wearable, the band, strap, or other wearable may be formedentirely or partially from a hydrophobic, gas permeable material and mayinclude an analyte sensitive material.

Such bands, straps, or wearables including at the least the detectingcomponent 113 of the detector 100 may include a gas permeable portionthat facilitates analytes from the subject reaching the detectingcomponent 113. Example materials for the gas permeable portions of thebands, straps, and/or wearables may include, but are not limited to,cotton, gauze, fabric, woven material, porated plastic, and/or othersuitable gas permeable materials.

Further, the bands, straps, or wearables may be used and/or configuredto stimulate analyte production from a subject's anatomy. Any suitabletechnique may be utilized for inducing analyte production including, butnot limited to, the techniques discussed herein.

When configured as a band, strap, or other wearable, the detector 100may have any suitable configuration and/or dimensions configured to beplaced on or proximate to the target location (e.g., surface 126 of skin124, a wound, etc.) of the subject over a short and/or an extendedperiod of time for the purpose of detecting analytes emitted, excreted,secreted, emanated, or released from the target location. Examplediameters or widths of the detecting component 113 of the band, strap,and/or other wearable may be less than or greater than 1 millimeter(mm). In some cases, the detecting component 113 incorporated in or inthe form of a band, strap, or other wearable may have a diameter orwidth in a range from about 1 mm to about 10 centimeters (cm), adiameter or width in a range of about 1 mm to about 1 cm, or othersuitable width or diameter, as desired. In one example of setting thediameter or width, a diameter or width of the detecting component 113may be configured or set based on target area sizes and differentdiameters or widths of detecting components 113 may be utilized fordifferent sizes of target locations so as to minimize or reduce the sizeof the detecting component 113 while maximizing detection of analytesfrom the target location over time, but this is not required. Otherfactors may be utilized and are contemplated for setting widths ordiameters of the detecting component 113.

FIG. 9 depicts an illustrative detector configured as a wearable 900(e.g., in band or strap form, as depicted) and positioned on the skin124 of a subject's wrist or arm 903. Among other components, thewearable 900 may include the detecting component 113 (e.g., representedby broken lines) incorporated into a band or strap 917 configured to beworn around a subject's arm 903 or other suitable extremities. When theband or strap 917 is worn around the subject's arm 903, the detectingcomponent 113 may be positioned at or adjacent to a target location(e.g., a skin surface, wound, wound dressing, etc. on the subject's arm903) so as to be able to detect analytes from the target location.Although the wearable 900 is depicted with only the detecting component113, the wearable 900 may include, among other components, the targetfacing component 111, the cover component 115, and/or a housing.Further, in some cases, the wearable 900 may be fixed at or adjacent thetarget location using the band or strap 917, but this is not required.

FIGS. 10-12 depict various views of the detector 100 in the form of awearable. FIG. 10 depicts a top view of the detector 100 on a subject'sarm or wrist 903. FIG. 11 depicts a cross sectional view of the detector100 on the subject's wrist or arm 903, taken along line 11-11 in FIG. 10. FIG. 12 depicts a bottom view of the detector 100 depicted in FIG. 10.

The detector 100 depicted in FIG. 10 is positioned at or over a targetlocation 1034 on the subject's wrist or arm 903. The detector 100 may beconfigured in a manner similar to the detectors discussed herein and mayinclude the target facing component 111, the detecting component 113,and the cover component 115, where the target facing component 111 andthe cover component 115 may define the space or opening 122. Thedetecting component may include dots of analyte sensitive material 128applied to the substrate 130, which may be viewable through atransparent or clear material of the cover component 115.

As discussed in greater detail below, the dots and/or otherconfigurations of the analyte sensitive material 128 of the detectingcomponent 113 may be arranged in one or more desired patterns. Further,as discussed herein, the analyte sensitive material 128 may be viewedfrom a top of the substrate 130, a bottom of the substrate 130, or bothfrom a top and a bottom of the substrate 130.

As depicted in FIG. 11 , the detector 100 may be applied to the targetlocation 134 on the subject's arm or wrist 903 and may include bands orstraps 917 extending around the subject's arm or wrist 903 to secure thedetector 100 at or adjacent the target location 134. The band or straps917 may include two portions (e.g., as depicted in FIG. 11 ) and/orother suitable number of portions configured to secure the detector ator around subject's arm or wrist 903. In some cases, the band or straps917 may include a single portion configured to extend from the detector100, around the subject's anatomy, and back to the detector 100.

The band and/or straps 917 may include any suitablecomponents/configurations configured to secure the detector 100 at thetarget location 1034 of the subject. When a plurality of bands and/orstraps or portions thereof are utilized, the bands and/or straps 917 orportions thereof may engage one another (e.g., with a buckle, fasteners,hook-loop materials, tie connection, etc.) to grab the subject's arm orwrist 903 and/or otherwise secure the detector at the target location1034. Alternatively or additionally, the bands and/or straps 917 may beconfigured with an elastic or resilient material to secure the detector100 at the target location 1034.

The bottom view of the detector 100 depicted in FIG. 12 shows the bandor straps 917 extending from outer sides of the target facing component111. Although the band or straps 917 are depicted as extending fromsides of the target facing component 111, the band or straps 917 mayextend from other suitable portions of the detector 100 and/or encompassan entirety of the detector 100. Further, although the analyte sensitivematerial 128 depicted in FIG. 10 is not depicted in FIG. 12 , in somecases, the analyte sensitive material 128 may be viewed from a top view,a bottom view, or both of the detecting component 113, as discussedherein.

As discussed herein, the analyte sensitive materials 128 of thedetecting components 113 may be arranged or configured in one or moremanners. For example, analyte sensitive material 128 may be arranged onthe substrate 130 in a random manner and/or in one or more predeterminedpatterns. In some cases, the analyte sensitive materials may be selectedand/or applied to the substrate 130 in a manner that facilitatesidentifying specific analytes. When the detector 100 includes suchanalyte sensitive materials 128, the detector 100 may be configured todetect a plurality of types of analytes, but this is not required. Afterexposure to analytes, the analyte sensitive materials may be analyzed bya machine (e.g., with a computer vision algorithm and/or other suitabletechniques) and/or by human vision.

FIGS. 13A and 13B depict an example detecting component 113 of adetector 100 having numbers (e.g., one through twelve, as depicted inFIGS. 13A and 13B, or other suitable numbers) in a margin 1336 (e.g., acircular margin, which may be clock-like, as depicted in FIGS. 13A and13B, a rectangular margin providing row and column numbers/identifiers,and/or other suitable configurations for identifying analyte sensitivematerials) outside of and/or around various types of analyte sensitivematerial 128 applied to the substrate 130. Each line of dots from acenter dot out to a number in the margin 1336 may be formulated from adifferent type of analyte sensitive material 128, where each type ofanalyte sensitive material may be configured to detect a differentanalyte from the subject's anatomy. A key may be provided to indicatewhich number is associated with which type of analyte (e.g., a type ofanalyte configured to detect a type of pathogen, bacteria, condition ofthe subject, etc.). In some cases, the length of the line from thecenter dot (e.g., a number of dots that react) may indicate a strengthor quantity-present of the detected analyte, but this is not required.

FIG. 13A depicts the detecting component 113 prior to exposure toanalyte from the subject's anatomy. FIG. 13B depicts the detectingcomponent 113 after exposure to analyte from the subject's anatomy. Ascan be seen in FIG. 13B from the dots changing appearance between FIGS.13A and 13B, a line of analyte sensitive material 128 extending from acenter dot to a number six in the margin 1336 has reacted to analytes towhich the detector 100 was exposed. Similarly, a line of analytesensitive material 128 extending from the center dot to the number tenin the margin 1336 has reacted to analytes to which the detector 100 wasexposed. As such, the detector 100 has detected two distinct analytes inthe flow of analytes from the subject's anatomy and a key may beaccessed and utilized to determine which analytes were detected.

As referred to, the detecting component 113 may indicate the strength orquantity of the detected analyte. For example, the center dot of theanalyte sensitive material 128 may be configured to react to any or allanalyte material (e.g., at least react to the different types ofanalytes the detector 100 is configured to detect) as an indication thedetecting component 113 has been exposed to relevant analyte material. Achange in a dot of a second ring of dots of the analyte sensitivematerial 128 (e.g., in the lines from the center dot to the number sixand the number ten, as depicted in FIG. 13B) may indicate at least afirst level of a type of analyte material for that line or ray ofanalyte sensitive material 128 was detected. A change in a dot of athird or outer ring of dots of the analyte sensitive material 128 (e.g.,in the line from the center dot to the number six, as depicted in FIG.13B) may indicate at least a second level of a type of analyte materialfor that row of analyte sensitive material 128 was detected. As such,FIG. 13B may indicate the detecting component 113 was exposed to atleast a first level of an analyte indicative of a first pathogen,analyte, bacteria, and/or condition and at least a second level of ananalyte indicative of a second pathogen, analyte, bacteria, and/orcondition, where the first level is greater than the second level. Othersuitable configurations are contemplated

In some cases, a portion of the detecting component 113 may be utilizedas a control set or pattern of analyte sensitive material 128 that isconfigured to not react with analyte material to which the detectingcomponent 113 is exposed. In such cases, the portion of the detectingcomponent 113 that may be utilized as the control set of analytesensitive material 128 may be compared to a portion of the analytesensitive material 128 that is configured to react to the analytematerial to which the detecting component 113 is exposed to confirmwhether the reactive analyte sensitive material 128 does actually detecta particular type of analyte or otherwise react to the analyte materialfrom the subject. The control portion of the analyte sensitive material128 may be utilized by a human or computer vision algorithm to confirmand/or improve analysis of the exposed detecting component 113 ascompared to an analysis without a control portion of the analytesensitive material 128.

Further, the detecting component 113 may be configured with differentarrangements of the analyte sensitive material 128, such as therow/column and clock-like configurations discussed above and/or othersuitable configurations. For example, the analyte sensitive material(s)128 may be configured on the detecting component 113 to form variousdesired patterns to indicate various parameter information concerninganalyte exposed to the detecting component 113, as desired. For example,the analyte sensitive material may have different chemicalconfigurations and/or may be applied in various quantities and/orpatterns to indicate parameter information related to the analyteexposed to the detecting component 113. Example parameter information ofthe analyte exposed to the detecting component 113 may include, but isnot limited to, analyte type detected, a number of different analytetypes detected, analyte quantity, etc.

FIG. 14 depicts a detecting component 113 that may be configured todetect a predetermined analyte type indicative of a pathogen orcondition of the subject that is to be detected using the detectingcomponent 113. As depicted in FIG. 14 , the detecting component 113 mayprovide an indication 1438 of the pathogen or condition of the subjectto be detected. Although FIG. 14 includes the indication 1438 of thepathogen or condition (e.g., streptococcus) to be detected that isreadable by a human prior to exposure to an analyte, the indication 1438may only appear if the analyte is detected (e.g., the indication 1438may be configured from an analyte sensitive material 128) and/or theindication 1438 may be encoded and configured to only be readable with adecoding system (e.g., a manual decoder, such as a mask or othersuitable manual decoder, or a computerized or electronic decoder). Suchencoded/decoding may be utilized for maintaining the privacy of theresults of using a detector incorporating the detecting component 113.Further, the detecting component 113 may include the analyte sensitivematerial 128 applied to the substrate 130 to form a recognizable symbol1440 that may be indicative of a positive test or otherwise indicativeof detecting an analyte that was tested-for (e.g., a plus symbol, asdepicted in FIG. 14 , and/or other suitable symbol).

FIGS. 15 and 16 depict example configurations of detecting components113 including the analyte sensitive material 128 applied to thesubstrate in an encoded format that is readable by computer visionalgorithms (e.g., a quick response (QR) code as depicted in FIG. 15 , abarcode as depicted in FIG. 16 , other suitable one-dimensional ortwo-dimensional barcodes, and/or other suitable encoded patterns thatare recognizable by hardware/software configured to detect the pattern)when the analyte sensitive material 128 reacts with an analyte to bedetected. In one example, the analyte sensitive material 128 may beapplied to the substrate 130 such that the analyte sensitive material128 may change in color or other suitable appearance to a particularpattern when the analyte sensitive material 128 is exposed to an analytethe analyte sensitive material 128 was configured to detect.

FIGS. 17-19 depict a system that includes a detecting component 113 anda mask 1842. Although a generally rectangular configuration of thedetecting component 113, the mask 1842, and features thereof is depictedin FIGS. 17-19 , other shapes and/or orientations are contemplated.

FIG. 17 depicts a detecting component with a plurality of dots ofanalyte sensitive material 128 applied to the substrate 130 of thedetecting component 113. Each dot of the analyte sensitive material 128may be configured to react to particular types of analyte, such thatwhen a particular type of analyte is present, the dots configured todetect that type of analyte form a pattern.

The mask 1842 may take on any suitable configuration. As depicted inFIG. 18 , the mask may be a physical component that is analyte orpathogen/condition specific and includes a plurality of openings 1844therethrough that form a pattern associated with the pathogen/condition,but this configuration is not required. Further, the mask 1842 mayinclude an indication 1438 of the pathogen/condition to be detected(e.g., Pathogen A or other suitable pathogen) and information 1846 thatmay indicate how a reactive analyte sensitive material 128 that hasreacted with the pathogen/condition associated with the pattern may lookthrough the opening 1844 (e.g., “ALL RED”).

Masks having configurations in addition to or as an alternative to aparticular set of openings, as depicted in FIG. 18 , are contemplated.In one example, a mask may be or include a color decoding maskconfigured to be indicate certain colors at certain positions on thedetecting component 113 indicate a pathogen/condition. In anotherexample, the mask may be or include one or more filters that emphasizesa presence/absence of a specific wavelength or wavelengths of lightreflected by the analyte sensitive material 128, where thepresences/absence of a specific wavelength or wavelengths of light mayindicate a pathogen/condition.

In some cases, the openings 1844 of the mask 1842 may include a colordecoding feature, an optical filter, an optical magnifier, and/or othersuitable feature that facilitates analyzing reactions of the analytesensitive material 128. Further, adjacent each of the openings 1844, themask 1842 may include color material that is the same as or similar to acolor of the analyte sensitive material 128 prior to the analytesensitive material reacting to a detected an analyte.

Further as depicted in FIGS. 18 and 19 , the mask 1842 may, optionally,include one or more alignment features 1848 to facilitate aligningand/or registering the detecting component 113 with the mask 1842. Whenthe mask 1842 includes alignment features, the detecting component 113may be engaged with the alignment features 1848 and the dots of thedetecting component 113 may align with the openings 1844 in the mask1842. If the analyte sensitive material 128 of the dots that align withthe mask 1842 appear as provided in the information 1846 (e.g., ALLRED), then it may be determined that the pathogen/condition (e.g.,Pathogen A) associated with the mask 1842 was present in the analytesthat were exposed to the detecting component 113.

In addition to or as an alternative to the physical mask 1842, numbersmay be located on or next to the analyte sensitive material 128 of thedetecting component 113. Then, a key may be provided that associatescertain numbers (e.g., dots 1, 5, 6, and 9 when numbered left-to-right,top-to-bottom) associated with certain reactions of the analytesensitive material 128 (e.g., the analyte sensitive material 128 turnsred), where the certain numbers and certain reactions is indicative of adetected analyte, pathogen, bacteria and/or condition of the subject(e.g., Pathogen A). Other suitable keys and configurations of thedetecting component are contemplated that may be analyzed and/orassessed by a human and/or computing device.

FIG. 20 depicts a detector 100 that includes a transparent covercomponent 115, a detecting component 113 in an opening 122, and a targetfacing component 111, which is configured similar to the detector 100depicted in and discussed with respect to FIG. 5 , while also includingtubing 2050. The tubing 2050 may be in communication with one or morepumps and may facilitate applying a flow of fluid to the opening 122 anda target location on the subject's anatomy and/or removing a flow offluid from the opening 122 and the target location on the subject'sanatomy. The fluid maybe provided to and/or removed from opening 122once the detector 100 is applied to the target location to facilitateapplying a turbulent flow to and/or above the target location forinducing analyte production and/or interaction with the detectingcomponent 113. Further, although not required, analyte from the targetlocation may be removed from the opening 122 and collected for analysisat a location spaced from the detector 100 and/or the removed analytemay be pumped back into the opening 122 for interacting with thedetecting component 113. Applying and/or removing fluid from the opening122 may be configured to concentrate analytes from the target locationat and/or around to the detecting component 113 to facilitate detectionof the analyte.

The tubing 2050 may including any suitable number of tubing componentsand/or any suitable configuration of the tubing 2050 to facilitatedetecting analytes. As depicted in FIG. 20 , the tubing 2050 may includean inlet tubing 2050 a configured to provide a flow of fluid to theopening 122 and an outlet tubing 2050 b configured to remove a flow offluid from the opening 122. Each of the inlet tubing 2050 a and outlettubing 2050 b may be connected to separate pumps (e.g., an inlet pumpand an outlet pump) or the inlet tubing 2050 a and the outlet tubing2050 b may be connected to a single pump that is capable of creating apositive pressure in the opening 122 through the inlet tubing 2050 a anda negative pressure in the opening 122 through the outlet tubing 2050 b.

In some cases, the outlet tubing 2050 b and/or other tubing 2050extending within the opening 122 (e.g., the inlet tubing 2050 b and/orother suitable tubing when it extends into the opening 122) may includeholes or openings to form a manifold along a length or a portion of alength of the outlet tubing 2050 b. Such a configured tubing 2050 may beutilized to provide localized pressure and/or turbulence to agitateand/or stimulate movement of analytes from subject's anatomy toward thedetector 113.

Further, tubing 2050 and the opening 122 may create a closed loop systemin which the fluid is pulled from the opening 122 through the outlettubing 2050 b and provided back to the opening 122 through the inlettubing 2050 a. Alternatively, the tubing 2050 and the opening 122 may bean open loop system where fluid is provided to the opening 122 from anambient source or other suitable sours, which may or may not includefluid from the opening 122.

In some cases, the fluid flow from the outlet tubing 2050 b may beprovided to a remote detector (e.g., a detector spaced from the detector100 from which fluid is removed through the outlet tubing 2050 b) orstorage container for later analysis. In one example use of a detector100 including the tubing 2050, fluid may be provided to the opening 122through the inlet tubing 2050 a and circulated in the opening 122therein for a desired or sufficient period of time to gather analytes atthe detecting component 113 and/or otherwise to accurately assess and/oranalyze the analytes from the target location on the subject.

Fluid circulation through the tubing 2050 and the opening 122 may beperformed with a uniform flow rate and/or it may be performed withnon-uniform flow rates (e.g., a pulsing flow rate or other suitablenon-uniform flow rate) to induce turbulence and mixing of analyteswithin the opening 122. Further, the flow rate may be a relatively highflow rate (e.g., of or about 300 cm³/min), a relatively low flow rate(e.g., of or about 4 cm³/min), and/or values therebetween, which may befixed prior to creating the flow and/or adjustable during the flow(e.g., automatically and/or manually adjustable based on a sensedparameter (e.g., temperature, humidity, quantity of analytes, detectionof analytes, etc.) and/or other suitable factors). Example flow ratesmay be less than 40 cm³/min, greater than 600 cm³/min, and/or in a rangeof or about 40 cm³/min to 600 cm³/min. In another example, the flowrates may be in a range of or about 4 cm³/min to 300 cm³/min.

As depicted in FIG. 20 , the tubing 2050 may enter into the opening 122through a side of the detector 100, however, other suitableconfigurations are contemplated. The inlet tubing 2050 a may terminateat one end of the opening 122 and the outlet tubing 2050 b may terminateat a second end of the opening 122, which may facilitate the flow offluid interacting with analytes from the target location.

FIG. 21 depicts a side view of the detector 100 depicted in FIG. 20 ,taken from a side opposite the side at which the tubing 2050 may enterthe detector 100. As represented in FIG. 21 , the tubing 2050 may enterthe detector 100 and the opening 122 through the target facing component111, but other suitable configurations are contemplated.

FIG. 22 depicts a cross-sectional view of a detector 100 similar to theview of the detector 100 in FIG. 8 that includes supports 132. When thetubing 2050 is included with the detector 100 and fluid is activelymoved within the opening 122, the supports 132 may facilitate supportinga flexible cover component 115 and a detecting component 113 at alocation (e.g., a consistent location) spaced from the target locationon the subject.

Although FIGS. 20-22 depict configurations of the detector 100 thatinclude the tubing 2050 for use in inducing fluid flow in the opening122, pressures and/or fluid flow in the opening 122 may be applied orchanged in one or more other suitable manners. In one example, when thetarget facing component 111, the detecting component 113, and/or thecover component 115 is flexible, a user may be able to manually flex orpush one or more components of the detector 100 to induce a fluid flowand/or change pressure in the opening 122. In a further example, thedetector 100 may include a one-way valve that allows fluid to leave theopening 122 and does not allow fluid to enter the opening 122. When thedetector 100 is secured around the target location of the subject andthe detector 100 is flexible and resilient, a user may create a negativepressure in the opening 122 by applying a force to the cover component115 or other suitable portion of the detector 100 to cause the detector100 to flex and then removing the force to allow the detector 100 toreturn to its previous shape and draw analyte from the target locationas it returns to its previous shape. In some cases, the detector 100 mayinclude one or more valves to facilitate adjusting pressures in theopening 122. Other suitable configurations are contemplated for creatingflows and/or changes of pressure in the opening 122.

FIG. 23 depicts a schematic diagram including a cross-sectional view ofan illustrative configuration of a detector 2300 configured tofacilitate use of a flow of fluid to detect analytes from the skin 124of the subject. The detector 2300 may be similar to the detector 100described above, where a target facing component 2311 may be a conduitcomponent 2360 configured to direct the fluid flow to a target location(e.g., the subject's skin 124, a wound, etc.) and to a detectingcomponent 2313. The detector 2300 may further include a cover component2315. FIG. 24 depicts a bottom view of the detector 2300 depicted inFIG. 23 . Although not depicted in FIG. 23 , a pump system may be partof or coupled to the detector 2300.

The detector 2300 depicted in FIG. 23 may be placed directly on thesurface of a target location (e.g., the surface 126 of the skin 124 ofthe subject) or could be held above (e.g., proximal of) the surface. Insome cases, allowing for a space between at least a portion of thebottom surface 2320 of the detector 2300 and the target location of oron a subject may facilitate detecting analytes and maintainingcleanliness and/or sanitation of the detector 2300. When a space betweenat least a portion of the bottom surface 2320 of the detector 2300 andthe surface 126 is desired, the bottom surface 2320 of the detector 2300may be held by a user or a mechanical support at a location spaced fromthe surface of the target location, a disposable or reusable componentmay extend between the bottom surface 2320 of the detector 2300 and thesurface of the target location as a standoff (e.g., the standoff may bethe conduit component 2360 or may be a component that is used inaddition to the conduit component 2360), the detector 2300 may be partof or placed in a wound dressing of a subject that spaces the bottomsurface 2320 of the detector 2300 from the surface 126, and/or othersuitable configuration may be used.

In some cases and similar to as discussed above, the detector 2300 mayfacilitate providing a fluid flow at positive pressure, represented byarrows P, to the surface of the target location (e.g., the surface 126of the skin 124 of the subject, as depicted in FIG. 4 ) and applying aflow of fluid at a negative pressure, represented by arrows N, at alocation interior of the location at which positive pressure is appliedto draw the flow of fluid and analytes (e.g., as represented by arrows2366) from or from proximate to the surface of the target location tothe detecting component 2313. Further, the detector 2300 may include theconduit component 2360 having a vacuum port or channel 2362 fordirecting the negative pressure fluid flow toward the detectingcomponent 2313 and a supply port or channel 2364 for directing thepositive pressure fluid flow toward the target location.

Arrows R represent a return of the flow of fluid to the detector 2300(e.g., from a pump) and arrows T represent a transition of the flow offluid through the detector 400 from positive pressure to negativepressure. In operation, as the fluid flow transitions from being underpositive pressure to negative pressure, the analytes may be added toand/or mixed with the fluid flow and directed toward the detectingcomponent 2313. Other configurations, however, are contemplated and thenegative pressure fluid flow and the positive pressure fluid flow may belocated at one or more other suitable locations or positions relative toone another. Further, the negative pressure fluid flow and the positivepressure fluid flow may be dependent on one another or may beindependent of one another.

The conduit component 2360 may be made of any suitable material and mayhave any suitable configuration. In some cases, the conduit component2360 may be formed from material similar to and/or configured similar tothe material and/or configuration of the target facing components and/orthe cover components, discussed herein. In one example, the conduitcomponent 2360 may be configured from conformable foam.

As depicted in FIG. 24 , the conduit component 2360 may be formed fromtwo concentric rings, but other designs and configurations arecontemplated. The rings forming the conduit component 2360 may be fixedrelative to one another via other layers of the detector 2300 and/ordirectly connected to one another. Although the detector 2300 may haveother configurations, an inner circumference of the outer ring and anouter circumference of the inner ring may define the supply channel 2364for receiving a fluid flow at a positive pressure and an innercircumference of the inner ring may define the vacuum channel 2362 forreceiving a fluid flow at a negative pressure, where the supply channel2364 and the vacuum channel 2362 may extend from the bottom surface 2320to the detecting component 2313.

FIG. 25 depicts a schematic illustrative configuration of the detector2300 including or otherwise in communication with a pump 2570, where thedetecting component 2313 may be in contact with and/or coupled to theproximal end of the conduit component 2360, which is shown from a sideview. Although only one pump 2570 is depicted in FIG. 6 , it iscontemplated that the detector 2300 may utilize two or more pumps 2570.In one example, a first pump may be for pumping a fluid flow into thedetector 2300 (e.g., at a positive pressure) and a second pump may befor pumping fluid flow out of the detector 2300 (e.g., at a negativepressure), but this is not required.

The pump 2570 may be any suitable type of pump. For the example, thepump 2570 may be a vacuum pump, a manually operated vacuum pump, anelectric powered vacuum pump, a pneumatically powered vacuum pump, anoscillating pump, a plenum, a pump in communication with a plenum,and/or any suitable device configured to create negative pressure,positive pressure, or both negative and positive pressure to draw afluid flow through or over the detecting component 2313. In someconfigurations, the pump 2570 may be configured such that the fluidinlet and the fluid outlet may induce a fluid flow vortex to createturbulent flow and to more efficiently gather analyte and direct theanalyte to the detecting component 2313.

To increase efficiency of harvesting and detecting analytes from thesurface of a target location (e.g., a skin surface of a subject, a woundof or on a subject, etc.), it may be advantageous to isolate the fluidflow in and out of the detector 2300 such that it creates an oscillatingmovement of fluid flow over the surface of the target location. In somecases, the oscillating movement of the fluid flow over the surface ofthe target location may produce a temporary vacuum seal of the detector2300 against anatomy of the subject to draw sweat and/or other suitableexcretions from the subject to increase analyte material to which thedetector 2300 may be exposed.

In one illustrative configuration, an oscillating airflow pump may beutilized. In one example, the oscillating airflow pump may have anoscillation range between approximately 0.1 Hz to approximately 1000 Hzto create oscillating movement of fluid flow over the surface of thetarget location. In another example, the oscillating airflow pump may beconfigured to create oscillating movement of fluid flow over the surfaceof the target location at an oscillation of about 4 Hz to about 7 Hz.The pressure induced by the oscillating pump could be mild or strong,ranging between approximately 0.001 atmospheres to 10 or moreatmospheres. Other suitable configurations of the oscillating airflowpump are contemplated to improve an efficiency of detecting from arounda surface of a target locations.

Although FIG. 25 depicts the pump 2570 in communication with the fluidflow through the vacuum channel 2362, the pump 2570 may not receive anoutput from the vacuum channel 2362. Instead, the pump 2570 may beconfigured to evacuate a plenum. After such evacuation, the plenum maybe sealed with a manual or automatic valve. The manual or automaticvalve may then be used as the supply of vacuum to be applied through thevacuum channel 2362. During evacuation, the fluid flow mixed withanalytes may be passed through or along the detecting component 2313 todetect analytes from the subject. Alternatively or additionally, themixture of fluid flow and analytes may be stored within the plenum forlater analysis.

FIG. 26 depicts a schematic illustrative configuration of the detector2600 including or otherwise in communication with a pump 2570 similar toas in FIG. 25 , where a detecting component 2613 is in contact withand/or coupled to a distal end of a conduit component 2660 (e.g., thedetecting component 2613 may be positioned between the conduit component2660 and a target facing component 2611). The conduit component 2660 maybe similar to the conduit component 2360, where the conduit component2660 may be considered a cover component 2615 of the detector 2600 andmay include a vacuum port or channel 2662 and/or a supply port orchannel 2664.

FIG. 27 depicts a schematic view of an illustrative configuration of adetector 2700. The detector 2700 depicted in FIG. 27 may include a base2772 (e.g., a target facing component 111 and/or other suitable base)and a cover 2774 (e.g., a cover component 115 and/or other suitablecover). Although not depicted, the cover 2774 and/or the base 2772 maybe transparent such that analyte sensitive material may be viewablethrough the cover 2774 and/or the base 2772.

Although not required in all configurations, the detector 2700 mayinclude a vacuum port 2776 formed from or otherwise extending from thecover 2774. The vacuum port 2776 may define a vacuum channel 2762configured for fluid communication with a pump, but this is notrequired.

The detector 2700 may take on any suitable shape or configuration. Forexample, the detector 2700 may have a circular profile (e.g., asdepicted in FIG. 27 ), a rectangular profile, a square profile, anamorphous profile (e.g., in response to be flexible and/or pliable),and/or one or more other suitable profiles.

FIG. 28 depicts a cross-sectional view taken along line 28-28 of theillustrative configuration of the detector 2700 depicted in FIG. 27 . Asdepicted in FIG. 28 , the detector 2700 may include the base 2772, thecover 2774, and a detecting layer 2775 (e.g., a detecting component 113and/or other suitable detecting layer). In some cases, the detectinglayer 2775 may be positioned between the cover 2774 and the base 2772,such that a fluid flow of analytes may be forced through or otherwisemove through or along the base 2772 and the detecting layer 2775 priorto exiting the detector 2700 through the vacuum channel 2762 and thevacuum port 2776. In some cases, the fluid flow of analytes directed orfocused over or through a small area (e.g., an area less than an entirearea) of the detecting layer 2775 (e.g., one or more locations ofanalyte sensitive material) to concentrate the analytes as the analytescontact the detecting layer 2775.

The detecting layer 2775, the base 2772, and the cover 2774 may beformed from any suitable materials and may have any suitableconfiguration. In some cases, one or both of the base 2772 and the cover2774 may be entirely or at least partially formed from elastomericand/or flexible materials to provide compliance when placed withpressure into contact with the surface (e.g., the surface 126 or othersuitable surface) of or adjacent to the target location (e.g., the skin124, wound, or other suitable target location) of the subject, but thisis not required and one or both of the base 2772 and the cover 2774 maybe made from rigid materials such as plastics, polycarbonates,polypropylene, polyethylene, ABS, and/or the like. In one example, thedetecting layer 2775, the base 2772 and the cover 2774 may be formed ofsimilar materials and in similar configurations as the detectingcomponents, the target facing components, and the cover components,respectively, discussed herein, but this is not required and one or moreof the detecting layer 2775, base 2772, and the cover 2774 may take onone or more other suitable configurations.

Although the detector 2700 is depicted as including a single detectinglayer 2775, two or more detecting layers 2775 may be utilized. Forexample, two detecting layers 2775 may be positioned in contact with oneanother or may be spaced apart from one another by spacers or othersuitable components of the detector 2700. In some cases, the twodetecting layers 2775 may be positioned so as to partially overlap oneanother, entirely overlap one another, or be spaced such that there isno overlap between the two detecting layers 2775. As discussed above,when two or more detecting layers 2775 are utilized, one or more may beconfigured to a particular type of analyte and/or one may be a controldetecting layer 2775 configured to be compared to a reacting detectinglayer 2775. When included, the control detecting layer 2775 may have asame or similar layout (e.g., analyte sensitive material layout) as thereacting detecting layer 2775, but the control detecting layer 2775 maybe configured so as to not react to exposure to analytes and thereacting detecting layer 2775 may be configured to react when exposed tothe analytes.

FIG. 29 depicts a schematic exploded view of the detector 2700 depictedin FIG. 27 . The detecting layer 2775 is depicted in FIG. 29 as having adisc-like form, but other configurations are contemplated.

As depicted in FIG. 29 , the detector 2700 may be assembled by placingthe detecting layer 2775 into the base 2772 and the cover 2774 may beplaced over the detecting layer 2775. In some cases, a friction fit, asnap connection, and/or other suitable connection may be made betweenthe base 2772 and the cover 2774 to assemble the detector 2700. Thecomponents of the detector 2700 may be separated (e.g., to remove thedetecting layer 2775 for analysis, to sanitize the detector 2700, etc.)by separating the cover 2774 from the base 2742 and removing thedetecting layer 2775 from the base 2772. Alternatively, the componentsof the detector 2700 may be sealed such that the components of thedetector 2700 may not be separated without destroying the detector 2700.

The detecting layer 2775 may be or include a substrate 2730 similar tothe other substrates discussed herein. Further, as depicted in FIG. 29 ,dots of analyte sensitive material 2728 have been applied to thesubstrate 2730. Although the dots are provided in rows and columns,other configurations are contemplated as discussed herein and/orotherwise.

Once the detecting layer 2775 has been exposed to a desired amount ofanalyte, the detecting layer 2775 may be separated from other componentsof the detector 2700 and analyzed. Alternatively or additionally, anentirety of or additional portions of the detector 2700 may be analyzed.

As depicted in FIG. 29 , the base 2772 may include one or more ridges2778 facing the detecting layer 2775. In some cases, the ridges 2778 inthe base 2772 may be configured to position or maintain the detectinglayer 2775 above a surface of the base 2772 defining openings 2780 inthe base 2772 to allow fluid flow through the openings 2780, between thebase 2772 defining the openings 2780, and through or along the detectinglayer 2775. As such, upon creation of a negative pressure with a pump(e.g., the pump 2570 or other suitable pump), a fluid flow with analytesmay be drawn through the base 2772, via the openings 2780, and throughand/or around the detecting layer 2775. As the fluid flow passes throughor along the detecting layer 2775, analytes may react with the detectinglayer 2775 for analysis and the fluid flow may pass into contact withthe cover 2774 and out through the vacuum port 2776.

Although the ridges 2778 are depicted in FIG. 29 as elongated raisedsurfaces being circumferentially equally spaced and extending radiallyoutward from a center portion of the base 2772 to a portion of the base2772 near an outer circumference, the ridges 2778 may take on anysuitable configuration to create a space between the base 2772 and thedetecting layer 2775 that facilitates fluid flow through the openings2780, between the base 2772 defining the openings 2780, and throughand/or around the detecting layer 2775. Example ridge 2778configurations include, but are not limited to, elongated raisedsurfaces, continuous raised surfaces, non-continuous raised surfaces,grid-like raised surfaces, concentric circle raised surfaces, depressedsurfaces, etc. Additionally or alternatively, ridges 2778 may extendfrom the detecting layer 2775 and/or may be formed from a componentseparate from the base 2772 and the layer 2775. In some cases, theridges 2778 may be omitted.

Although the openings 2780 are depicted in FIG. 29 as beingcircumferentially equally spaced and having a triangular shape extendingradially inward toward the center portion of the base 2772 from aportion of the base 2772 near the outer circumference, the openings 2780may take on any suitable configuration to create an opening between abottom surface 2720 of the base 2772 and an interior surface 2790 of thebase 2772 that facilitates fluid flow through the base 2772. Exampleconfigurations for the openings 2780 include, but are not limited to,configurations with triangular profiles, circular profiles, elongatedprofiles, rectangular profiles, oval profiles, square profiles, etc.

FIG. 30 depicts a bottom perspective view of the base 2772. In additionto the openings 2780, the base 2772 may be configured to define orotherwise include one or more notches 2792. The notches 2792 may beconfigured to allow ambient airflow to be drawn through the base 2772and into a space 2794 underneath the bottom surface 2720 of the base2772 that is in fluid communication with the openings 2780. Further, thenotches 2792 may facilitate preventing the surface of the targetlocation or liquid (e.g., sweat and/or other liquids) from being drawninto and/or around the detecting layer 2775.

In some cases, utilizing the notches 2792 in the base 2772 may mitigatea need to provide a fluid flow at a positive pressure to an areaproximate the surface (e.g., the surface 126 or other suitable surface)of the target location (e.g., the skin 124, a wound, a wound dressing,or other suitable target location) of or on the subject (e.g., the fluidflow supply from the pump may be omitted, as desired). For example, inoperation of the detector 2700, the base 2772 may be placed on oradjacent the target location of the subject, and a negative pressurefluid flow may be created by a pump connected to or otherwise in fluidcommunication with the detector 2700 that draws fluid through thenotches 2792, into the space 2794 adjacent the target location andallows the fluid flow to mix with analytes, then draws the mixed fluidflow through the openings 2780 into contact with the detecting layer2775 to detect the analytes in the fluid flow, after which the fluidflow may exit the detector 2700 through the cover 2774. Otheroperational configurations are contemplated.

FIG. 31 is a bottom perspective view of the cover 2774. As depicted inFIG. 31 , the cover 2774 may include one or more ridges 2796 facing thedetecting layer 2775. In some cases, the ridges 2796 in the cover 2774may be configured to maintain, position, or orient the detecting layer2775 below an interior or bottom surface 2798 of the cover 2774 definingan opening 2718 that may lead to the vacuum channel 2762 defined by thevacuum port 2776. Such a configuration of the ridges 2796 may allow forthe negative pressure fluid flow to pass through or around the detectinglayer 2775, through a space between the detecting layer 2775 and thecover 2774 that may be at least partially defined by the ridges 2796contacting the detecting layer 2775, and exit the detector 2700 throughthe vacuum port 2776.

Although the ridges 2796 are depicted in FIG. 31 as elongated raisedsurfaces being circumferentially equally spaced and extending radiallyoutward from a center portion of the cover 2774 to a portion of thecover 2774 near an outer circumference, the ridges 2796 may take on anysuitable configuration to maintain, position, or orient the detectinglayer 2775 relative to the cover 2774 and the opening 2718. Exampleconfigurations of the ridges 2796 include, but are not limited to,elongated raised surfaces, continuous raised surfaces, non-continuousraised surfaces, grid-like raised surfaces, concentric circle raisedsurfaces, etc. Additionally or alternatively, ridges 2796 may extendfrom the detecting layer 2775 and/or may be formed from a componentseparate from the cover 2774 and the layer 2775. In some cases, theridges 2796 may be omitted.

FIG. 32 is a schematic perspective view of the detector 2700 includingor otherwise coupled (e.g., hermetically coupled or coupled in one ormore other suitable manners) to a pump 2570 via the vacuum port 2776. Asdepicted in FIG. 32 , the pump 2570 may be a hand activated pump tomanually control vacuum pressure to the detector 2700 in order to allownegative pressure to draw analyte through the detector 2700, but this isnot required and the pump may be any other suitable pump discussedherein or otherwise.

Among other components, the pump 2570 may include a vacuum bulb 2781, afluid inlet 2784, and a fluid outlet 2782. In some cases, the fluidinlet 2784 and/or the fluid outlet 2782 may be or may include one-wayvalves to facilitate one-way directional flow through the pump 2570(e.g., fluid may flow in through the fluid inlet 2784 and fluid may flowout through the fluid outlet 2782). In operation, a user may manuallysqueeze the vacuum bulb 2781 to push fluid out of the fluid outlet andrelease the vacuum bulb 2781 to draw fluid into the pump 2570 throughthe fluid inlet 2784, such that fluid may be drawn into the detector2700, pass through or around the detector 2700, as described herein,pass into the pump 2570 through the fluid inlet 2784, and move out ofthe pump 2570 through the fluid outlet 2782. Other suitable manualand/or automated pump configurations are contemplated.

The vacuum bulb 2781 may formed from any suitable material. Examplematerials include, but are not limited to, elastomeric materials,rubber, silicone, and/or other suitable medical grade materials.

The fluid inlet 2784 and/or the fluid outlet 2782 may be formed from anysuitable materials and have any suitable configuration that may be thesame, similar, or different than a configuration of the other of thefluid inlet 2784 and the fluid outlet 2782. Example materials forforming the fluid inlet 2784 and/or the fluid outlet 2782 include, butare not limited to, plastics, metals, ceramics, and/or other suitablematerials. In one example configuration of the fluid inlet 2784 and thefluid outlet 2782, each may have a port or nipple to facilitatefastening and/or connecting directly to the vacuum port 2776 of thedetector 2700 and/or tubing defining a flow channel.

In the configuration of FIG. 32 , analytes may be drawn into reactivecontact with the analyte sensitive material 2728 of the detector 2700 inresponse to a vacuum pressure applied by the pump 2570. Although notrequired, fluid pumped out of the detector 2700 by the pump 2570 may bepumped back into headspace above a target location of the subject (e.g.,above skin, a wound, a wound dressing, etc.) to circulate analyte fluidthrough the detector 2700 and concentrate analyte material.

FIG. 33 depicts a schematic top perspective view of an illustrativeconfiguration of a detector 3300. As depicted in FIG. 33 , the detector3300 may include a base 3372 (e.g., a target facing component 111 and/orother suitable base) and a cover 3374 (e.g., a cover component 115and/or other suitable cover) defining a vacuum port 3376 and a vacuumchannel 3362. In some cases, the vacuum port 3376 may be configured toengage a fluid inlet 3384 of the pump 2570 similar to as depicted inFIG. 32 , but this is not required.

FIG. 34 depicts a schematic exploded bottom perspective view of theconfiguration of the detector 3300 depicted in FIG. 33 . In addition tothe base 3372 and the cover 3374, the detector 3300 depicted in FIG. 34may include a detecting tube 3391 (e.g., a detecting component 113and/or other suitable detecting tube) and an end cap 3393, but this isnot required. The detecting tube 3391 may include or may be a substrate3330 and analyte sensitive material 3328 may be applied thereto in amanner that the applied analyte sensitive material 3328 interacts withand reacts to analyte from a subject. In operation, the detector 3300depicted in FIGS. 33 and 34 may operate in a similar manner to the otherconfigurations of detectors described herein and/or in one or more othersuitable manners.

The detecting tube 3391 may be fabricated by applying (e.g., printingand/or applying in one or more other suitable manners) the analytesensitive material 3328 onto a substantially rectangular substrate 3330.Once the analyte sensitive materials 3328 has been applied to thesubstrate 3330, the substrate 3330 may be rolled into a tube shape priorto assembly into the cover 3374.

The cover 3374 may include a tube support 3388. The tube support 3388may be configured to support or otherwise provide stability to thedetecting tube 3391 when the detector 3300 is fully assembled. In somecases, the tube support 3388 may include one or more openings or slots3386 that may be positioned to allow a fluid flow to pass therethroughto or from the detecting tube 3391 and out of the detector 3300 throughthe vacuum channel 3362.

The detecting tube 3391 may be configured to detect and react toanalytes from a subject. As such, the detecting tube 3391 may beconfigured from similar materials as the materials used to form thedetecting components 113 described herein and/or other suitablematerials. Further, although the detecting tube 3391 is described as atube, the detecting tube 3391 may be considered a layer and/or take onone or more other suitable shapes or other configurations.

The end cap 3393 may be configured to be secured to the tube support3388. For example, the end cap 3393 may be secured to the tube support3388 using a snap connection, a luer lock connection, a threadedconnection, and/or one or more other suitable types of connections. Inone example, when the cover 3374 is in contact with the base 3372, thetube support 3388 may extend through the detecting tube 3391 and the endcap 3393 may extend through the base 3372 such that the tube support3388 and the end cap 3393 engage one another with a snap connection tocouple the components of the detector 3300 to one another. Although theend cap 3393 is described as a component separate from the base 3372,the end cap 3393 and/or the function of the end cap 3393 may beincorporated into the base 3372.

The end cap 3393 may be formed from any suitable material. In somecases, the end cap 3393 may be formed from a similar or differentmaterial than the base 3372 and/or the cover 3374. In some cases, theend cap 3393 may be made of a suitable elastomeric material, a rigidmaterial, and/or other suitable materials. In one example, a portion3393 a of the end cap 3393 configured to engage the tube support 3388may be formed from a substantially rigid material and a portion 3393 bof the end cap 3393 configured to engage the base 3372 may be formedfrom an elastomeric material, but this is not required.

In addition to the notches 3352, the base 3372 may include one or moreopenings 3380 extending thorough the bottom surface 3320 of the base3372. When the detector 3300 is assembled, the openings 3380 may createa flow path for a fluid flow that extends from a space defined by thebase 3372 and the target location of or on the subject (e.g., the skin124, a wound, etc.), through the openings 3380 and into a space definedby an exterior surface of the detecting tube 3391 and an inner surfaceof the cover 3374. Once the fluid flow is in the space between the cover3374 and the detecting tube 3391, the fluid flow may be suctionedthrough or along the detecting tube 3391, through the slots 3386 in thetube support 3388, and out of the vacuum channel 3362. In anotherexample flow path, the openings 3380 may be configured in the base 3372and relative to the cover 3374 such that the flow path extends throughthe openings 3380 and into a space defined by an interior circumferenceof the detecting tube 3391, through the detecting tube 3391 to the spacebetween the detecting tube 3391 and the cover 3374, and out of thedetector 3300, where the vacuum channel 3362 is configured in the cover3374 to evacuate the fluid flow from the space between the detectingtube 3391 and the cover 3374. Other suitable configurations arecontemplated.

The detectors 100, 900, 2300, 2600, 2700, 3300, and/or the componentsthereof described herein may be manufactured by any suitable techniques.In some cases, the detector and/or the components thereof may bemanufactured by techniques to optimize desired properties including, butnot limited to, adhesiveness, flexibility, porosity, non-porosity,adsorbent properties, compatibility with adjacent layers,tear-resistance, tensile strength, durability, shear strength (betweencomponents), and/or other suitable properties. In one example, advancedthree-dimensional printing or deposition techniques may allow forcustomized properties for each component or layer, such that thecomponents or layers may take on a uniform or predetermined compositionor a gradient composition or a matrix composition depending on theproperty for and within a component, as desired. Such techniques andconsiderations may be utilized when considering the overall desiredproperties of the detector, including, but not limited to, themechanical properties, cost, usability, manufacturability, durability,biocompatibility, etc. of detector.

The detectors 100, 900, 2300, 2600, 2700, 3300 described herein may beutilized in one or more methods of detecting analytes from the targetlocation of a subject. In one example, a method 3500 of using a detectorfor detecting analytes (e.g., VOCs and/or other chemical substances)emitted, excreted, and/or secreted from a target location (e.g., skin, awound, etc.) of or on a subject is provided, as depicted in FIG. 35 an.

The method 3500 may include cleaning or otherwise preparing 3502 atarget location surface of the subject for use with the detector (e.g.,where the detector is in contact with or spaced from the surface of thesubject from which analytes are to be detected). Cleaning or otherwisepreparing the target location surface for use with the detector mayinclude alcohol-swabbing the target location surface, washing the targetlocation surface, applying a sweat inducer to the target locations,and/or cleaning or preparing the target location surface in one or moreother suitable manners.

Further, before, while, or after preparing the target location surface,the detector may be removed from a sterilized packaging in which thedetector may be transported and/or stored. If the detector includes aseal or a release liner to protect adhesive on the detector and/or toprotect the detecting component, the seal or release liner may beremoved (e.g., removed from the target facing component and/or othersuitable component of the detector).

Further, the method 3500 may include positioning 3504 the detector at adesired location relative to the prepared surface of the target locationof or on the subject (e.g., on, or adjacent to and spaced from, thewound and/or skin surface of the subject that has been prepared for usewith the detector) and exposing a detecting component of the detector toanalytes from the target location. In some cases, the detector may bepositioned at a location that will facilitate receiving analytes at orthrough the detector. To facilitate positioning the detector, thedetector may be affixed at a desired location, may be held at a desiredlocation by a person, may be held at a desired location by a support,may be held at a desired location by a band or strap, and/or secured ata desired position in one or more other suitable manners.

When the detector includes an adhesive backing or is otherwiseconfigured to be used with adhesive, the adhesive may be exposed to thesurface at or adjacent to the target location of or on the subjectand/or a standoff positioned adjacent to the target location to securethe detector at the desired position. When applying the detector to theskin surface at a desired location, an adequate level of pressure may beapplied to the detector to create a seal between a bottom side of thedetector and the skin surface.

Although not required, after the detector has been positioned at adesired location relative to the prepared surface of the targetlocation, a pump may be utilized to facilitate detection of analytesfrom the subject. When using the detector with a pump, negative pressureand/or a positive pressure may be applied to the detector. For example,a pump may be connected to a vacuum port of the detector and a negativepressure may be applied across a detecting component. In some cases, thenegative pressure may be applied at a level and for a period of time toallow a suitable amount of analytes to emit, excrete, and/or secretefrom the target location, be drawn through or around the detectingcomponent, and be detected by the detecting component of the detector.

In some cases, the detector may create a seal or partial seal with thesubject's anatomy to contain analyte from the subject within thedetector for passive (or active) detection. After a sufficient amount oftime, while still sealed to the anatomy of the subject or after beingremoved from the anatomy of the subject, the analyte sensitive materialof the detecting component of the detector may be analyzed 3506 viahuman vision, computer vision, and/or other suitable techniques. Exampletechniques for analyzing analyte sensitive material are discussed hereinand additional or alternative techniques are known in the art. In oneexample, analyte sensitive material that has been exposed to analytesmay be compared to a key that provides a connection between analytesensitive material reactions to detected analyte and analyte(s),pathogens, bacteria, and/or conditions to determine which analyte(s),pathogens, bacteria, and/or conditions have been detected.

Further, the detector may be removed from the desired location relativeto the prepared surface. In one example, after a desired amount of timedetecting analytes and a suitable amount of analytes have been detectedsuch that the analyte sensitive material may be analyzed, the detectormay be removed from the desired location.

An amount of time the detector is at the desired location detectinganalytes may depend on one or more parameters. Example parametersinclude, but are not limited to, a type of analyte targeted, propertiesof interest from analyses of detected analytes, an amount of negativepressure applied to the detector, a temperature at the desired location,a pressure on a surface of the desired location, and/or other suitableparameters.

Once the detector has been removed from the desired location, thedetector or at least a detecting component of the detector may beanalyzed and/or transported for analysis. In some cases, the detectingcomponent of the detector may be removed from the detector afterexposure to analytes and detecting analytes, packaged in a tamper-proofpackage, and sent to a lab for a detailed analysis of the detectedanalytes.

This method 3500 and/or other methods of use may be performed entirelyor partially by one or more of the subject whose analytes are beingdetected and/or another person, such as a health care provider (e.g.,medical doctor, nurse practitioner, physician's assistant), technician,or other suitable person. The methods may also be entirely or partiallyrobotically performed or assisted by a machine or computing device. Suchmachine-assisted techniques may improve analyte detection outcomesthrough more consistent application of pressure to create the desiredseal between the detector and the surface of or adjacent the targetlocation, through consistent reading of the results of analytedetection, and/or through other suitable techniques.

The various methods of using the detector 100, 900, 2300, 2600, 2700,3300 described herein to detect analytes may be augmented orsupplemented by increasing analyte emittance, excretion, and/orsecretion by the body of the subject whose analytes are being detected.Because it is known that target analytes can reside in sweat, analyteemittance, excretion, and/or secretion may be increased by stimulatingsweat glands to increase sweat production. One way to induce orotherwise increase sweat by the subject may be to heat all or portionsof detector 100, 900, 2300, 2600, 2700, 3300, particularly portions incontact with the skin surface. Another option for inducing a subject tosweat is by applying chemical agents (e.g., gaseous and/or liquidchemical agents), for example carbachol and pilocarpine, to the skinsurface.

In some configurations, the detector 100, 900, 2300, 2600, 2700, 3300may include or may be used with one or more electrodes that are to beapplied to the skin of the subject as part of or an accompaniment to thedetector 100, 900, 2300, 2600, 2700, 3300 to create a voltage gradient,for instance at the microampere level of current, not only to createheat but also generate a vibrational element through the subject's skin.Such use of electrodes may drive sweat stimulating agents moreeffectively through skin. A similar process could be employed toincrease sebum production by sebaceous glands to additionally drivesebum to the skin surface, such that the detector 100, 900, 2300, 2600,2700, 3300 may extract and detect analytes emitting, excreting, orsecreting from the sebum of a mammalian subject, including a humansubject. All of these methods may be employed singly or in combination.

When using detectors 100, 900, 2300, 2600, 2700, 3300 on a wound, someof the analytes may be related to a bacterial infection, and others maybe the result of the subject's own metabolism, including from externalsources such as metabolized chemicals from food, drinks, and/orpharmaceuticals. It may be desirable to minimize detection or an effectof analytes that are not produced by the bacteria in the wound.Accordingly and as referred to above, it may improve accuracy ofanalysis to take a “control” detection of analytes and/or othersubstances on healthy skin (e.g., a target location) away from the woundsite. Then, during analysis of the analytes taken from the wound site,the reading from the healthy skin may be subtracted from the reading onthe wound site, substantially canceling out analytes that are unrelatedto the wound itself. Alternatively or additionally, the readings fromthe wound site may be normalized in one or more other suitable manners.

It will be understood that in any of the embodiments described above,the analysis of detected analytes can be used to identify bacteria in awound and/or to identify illnesses that alter the patient's metabolismin a way that elicits patterns of analytes specific to that particularillness. For example, the detected analytes and analyses thereof can beused to identify bacteria in a wound, identify illnesses that alter thesubject's metabolism in a way that causes them to emit, secret, emanate,release, and/or excrete patterns analytes specific to that particularillness, identify a wellness of the subject (e.g., one or more analysesresults in a measurement within a healthy range for the subject), and/ormake one or more other suitable identifications or determinations.

A variety of methods may be utilized to analyze analytes detected withthe detector 100, 900, 2300, 2600, 2700, 3300. Example detection and/oranalysis devices include, but are not limited to, a metal oxidesemiconductor (MOS) sensor-based device, a gas chromatography device(GC), a mass spectroscopy device (MS), GCMS, Raman spectroscopy device,near-infrared spectroscopy device (NIRS), a Fourier transform infraredspectroscopy device (FTIR spectroscopy), a terahertz spectroscopydevice, a chemical detector, a detector array, a UV, Visible,Near-Infrared (NIR) or Short-Wave-Infrared (SWIR) spectrometer, asurface-enhanced Raman spectroscopy device (SERS), other suitabledetection devices, and/or combinations thereof.

Hyperspectral imaging techniques and devices, similar to other spectralimaging techniques and devices, collect and process information fromacross the electromagnetic spectrum and may be useful for the analysisof detected analytes. The goal of such imaging is to obtain spectra foreach pixel in an image, with the intent of finding objects, identifyingmaterials, or detecting processes. Whereas the human eye sees color ofonly the visible light spectrum, in mostly three bands (longwavelengths—red, medium wavelengths—green, and short wavelengths—blue),hyperspectral imaging sees a broader range of wavelengths extendingbeyond the visible spectrum.

MS devices used to analyze detected analytes by the detector 100, 900,2300, 2600, 2700, 3300 and methods described herein may requireionization of the detected substances. Example ionization techniquesinclude, but are not limited to, electron impact (EI), thermaldesorption (TD), electrospray ionization (ESI), atmospheric pressurechemical ionization (APCI), and any other suitable ambient ionizationtechniques such as DART and DESI after VOC and/or chemical substancedesorption in order to analyze the collected sample.

Although the subject matter has been described in language specific tostructural features and/or methodological acts, it is to be understoodthat the subject matter defined in the appended claims is notnecessarily limited to the specific features or acts described above.Rather, the specific features and acts described above are disclosed asexample forms of implementing the claims.

Unless otherwise expressly stated, it is in no way intended that anymethod set forth herein be construed as requiring that its steps beperformed in a specific order. This holds for any possible non-expressbasis for interpretation, including matters of logic with respect toarrangement of steps or operational flow, plain meaning derived fromgrammatical organization or punctuation, and the number or type ofembodiments described in the specification

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of thedisclosure. This may include, to the extent that it is appropriate, theuse of any of the features of one example embodiment being used in otherembodiments. The invention's scope is, of course, defined in thelanguage in which the appended claims are expressed.

What is claimed is:
 1. A detector, comprising: a substrate; a detectorarray applied to the substrate and configured to detect a parameter ofan analyte from a target location of a subject's anatomy; and a targetfacing component configured to engage the subject's anatomy and definean opening between the target location and the substrate when engagingthe subject's anatomy; wherein the substrate is configured to orient thedetector array adjacent the target location of the subject's anatomy andexpose the detector array to the analyte from the target location. 2.The detector of claim 1, wherein: the target facing component has afirst surface configured to face away from the target location and asecond surface opposite of the first surface and configured to face thetarget location when the target facing component is engaged with thesubject's anatomy; and the detector array is applied to the firstsurface of the substrate.
 3. The detector of claim 1, wherein thesubstrate is a hydrophobic, gas permeable material.
 4. The detector ofclaim 1, wherein the target facing component is flexible.
 5. Thedetector of claim 1, further comprising: a cover extending over thedetector array, secured to the target facing component and thesubstrate, and defining the opening.
 6. The detector of claim 5, whereinthe cover is transparent and configured such that the detector array isanalyzable through the cover.
 7. The detector of claim 1, furthercomprising: a support extending through the opening and configured tomaintain a space between the subject's anatomy and the substrate whenthe target facing component is engaging the subject's anatomy.
 8. Thedetector of claim 1, further comprising: tubing configured to facilitateapplying a flow of fluid to the opening.
 9. The detector of claim 1,further comprising: a band configured to be worn by the subject againstskin of the subject; and wherein the detector array and the substrateare incorporated into the band such that the detector array is exposedto the target location of the subject's anatomy through the substratewhen the band is worn by the subject.
 10. The detector of claim 1,further comprising: a wound dressing configured to cover a portion ofthe detector array.
 11. The detector of claim 1, wherein: the detectorarray has a control pattern having a first configuration and an analytesensitive pattern having a second configuration that is substantiallysimilar to the first configuration; the control pattern is configured tobe non-reactive to the analyte from the subject; and the analytesensitive pattern is configured to react to the analyte from thesubject.
 12. A detector device comprising: a housing component; and adetecting component at least partially covered by the housing component;and wherein the detecting component is configured to detect a parameterof an analyte from a target location on a subject's anatomy and thehousing component is flexible and configured to define an openingbetween the target location and the detecting component.
 13. Thedetector device of claim 12, wherein the housing component includes atarget facing component and a cover component coupled to the targetfacing component.
 14. The detector device of claim 13, wherein thetarget facing component is configured to direct a fluid flow includingthe analyte from the target location of the subject's anatomy to thedetecting component.
 15. The detector device of claim 12, wherein thedetecting component comprises: a substrate secured to the housingcomponent; and an array of analyte sensitive material applied to thesubstrate and configured to chemically react to the analyte.
 16. Thedetector device of claim 12, further comprising: tubing configured towherein the detecting component is configured to passively detect theparameter of the analyte from the target location on the subject'sanatomy.
 17. A method of detecting analytes from a target location of asubject's anatomy, the method comprises: preparing a surface of thetarget location of the subject's anatomy for detection of an analytefrom the target location; positioning a detector at a desired locationand exposing a detecting component of the detector to the analyte fromthe target location via an opening between the target location and thedetecting component, the detecting component including a substrate andanalyte sensitive material applied to a side of the substrate facingaway from the target location; and analyzing the analyte sensitivematerial of the detecting component after the detecting component isexposed to the analyte from the target location.
 18. The method of claim17, wherein positioning the detector at the desired location includessecuring the detector at the desired location with an adhesive and themethod further comprises: removing the detector after a predeterminedtime at which the adhesive no longer adheres to the desired location.19. The method of claim 17, wherein positioning the detector at thedesired location includes securing the detector at the desired locationincludes securing the detector at the desired location with a band. 20.The method of claim 17, wherein exposing the detecting component to theanalyte from the target location includes pumping fluid including theanalyte across the detecting component.